Diaphragm Pumps and Pumping Systems

ABSTRACT

A process fluid pump can include a pump chamber, an inlet valve, and an outlet valve. Diaphragm regions can define at least a portion of each of the pump chamber, the inlet valve, and the outlet valve. The diaphragm regions can each have an actuation region with a surface that is convexly shaped when the formed actuation region is in a natural unstressed first state, and each formed actuation region can be actuated by a motive fluid to transition to a second state in which the surface is non-convexly shaped.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/945,177, filed Nov. 26, 2007, titled DIAPHRAGM PUMP AND RELATEDMETHODS, which is a continuation-in-part of U.S. application Ser. No.11/484,061, filed Jul. 11, 2006, titled DOUBLE DIAPHRAGM PUMP ANDRELATED METHODS, which claims priority to U.S. Application No.60/699,262, filed Jul. 13, 2005, titled DOUBLE DIAPHRAGM PUMP ANDRELATED METHODS; each of the foregoing applications is herebyincorporated by reference herein and made a part of this application.

TECHNICAL FIELD

Certain embodiments described herein relate generally to the field offluid transfer. More particularly, some embodiments described hereinrelate to fluid transfer having a relatively small amount or no amountof impurities introduced to the fluid being transferred and/orrelatively little or no damage to the fluid being transferred.

BRIEF DESCRIPTION OF THE DRAWINGS

Understanding that drawings depict only typical embodiments of theinvention and are not therefore to be considered to be limiting of itsscope, the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings. Thedrawings are listed below.

FIG. 1 is a perspective view of an embodiment of a double diaphragmblood pump.

FIG. 2 is an exploded perspective view of the double diaphragm bloodpump of FIG. 1.

FIG. 3 is a perspective view of an inner side of an embodiment of avalve plate.

FIG. 4 is a plan view of one side of an embodiment of a pump body with aportion of the interior of the pump body shown in phantom and a portionof an opposite side of the pump body shown in phantom.

FIG. 5 is a perspective view of the inner side of an embodiment of achamber plate with interior features thereof shown in phantom.

FIG. 6A is a perspective view of an embodiment of diaphragm media beforeregions have been formed.

FIG. 6B is a perspective view of the diaphragm media of FIG. 6A afterthe regions have been formed.

FIG. 7 is an exploded perspective view of an embodiment of a formingfixture used to form the regions in the diaphragm.

FIG. 8A is a cross-sectional view of a forming fixture after a diaphragmmedia has been loaded to form the regions in the chamber diaphragm.

FIG. 8B is a cross-sectional view such as the view in FIG. 8A showingthe forming fixture after the regions in the diaphragm media have beenformed.

FIG. 9A is a side view of the double diaphragm pump of FIG. 1 whichshows cutting lines 9B-9B and 9C-9C.

FIG. 9B is a cross-sectional view of the double diaphragm pump of FIG. 1taken along cutting line 9B-9B in FIG. 9A.

FIG. 9C is a cross-sectional view of the double diaphragm pump of FIG. 1taken along cutting line 9C-9C in FIG. 9A.

FIG. 10 is a cross-sectional view of another embodiment of the doublediaphragm pump of FIG. 1 taken along cutting line 9B-9B in FIG. 9Ashowing valve bypass passages.

FIG. 11 is a cross-sectional perspective view of another embodiment of adiaphragm pump.

FIG. 12 is a partially exploded perspective view of two double diaphragmblood pumps configured for operative association with a reusable pumpcontrol system.

FIG. 13A is a partial cross-sectional view of a double diaphragm pumpand manifold taken along cutting line 13A-13A in FIG. 12.

FIG. 13B is a partial cross-sectional view of a double diaphragm pumpand manifold taken along cutting line 13B-13B in FIG. 12.

FIG. 14 is a partially exploded perspective view of an embodiment of amanifold mounting assembly.

FIG. 15 is a perspective view of an embodiment of a manifold base with aportion of the interior features of the manifold base shown in phantom.

FIG. 16 is a schematic view of an embodiment of a double diaphragm pumpas used in a method and system for transferring fluid.

FIG. 17 is a schematic view of an embodiment of a cardiopulmonaryby-pass system that includes multiple double diaphragm pumps.

FIG. 18 is a schematic view of an embodiment of a heart-assist systemusing an embodiment of the double diaphragm pump.

FIG. 19 is a schematic view of an embodiment of a hemodialysis systemusing an embodiment of the double diaphragm pump to effect flow throughthe system.

FIG. 20 is a chart showing an example of the pressure over time of bloodentering and also of blood exiting an embodiment of a double diaphragmpump of the system depicted in FIG. 17 when configured for relativelyconstant flow operation.

FIG. 21 is a chart showing an example of the pressure over time of bloodentering and also of blood exiting an embodiment of a double diaphragmpump of the system depicted in FIG. 18 when the pump is configured forpulsatile outflow operation and relatively constant inflow operation.

FIG. 22A is a chart showing an example of the pressure over time ofblood entering and also of blood exiting an embodiment of a doublediaphragm pump of the system depicted in FIG. 19, as well as thepressure over time of blood exiting the dialyzer, when the pump isconfigured for use in a hemodialysis procedure and controlled forrelatively constant inflow operation and relatively constant outflowoperation.

FIG. 22B is a chart showing an example of the pressure over time ofblood entering and also of blood exiting the double diaphragm pump inthe system depicted in FIG. 19, as well as the pressure over time ofblood exiting the dialyzer, when the pump is configured for use in ahemodialysis procedure and controlled for relatively constant inflowoperation and pulsatile outflow operation.

INDEX OF ELEMENTS IDENTIFIED IN THE DRAWINGS

Elements numbered in the drawings include:

-   -   100 double diaphragm pump    -   100 a-h double diaphragm pumps    -   101 i first inlet valve chamber    -   101 o first outlet valve chamber    -   102 i second inlet valve chamber    -   102 o second outlet valve chamber    -   103 a first pump chamber    -   103 b second pump chamber    -   110 pump body    -   110′ pump body with valve bypass channels    -   111 i first inlet valve seat    -   111 o first outlet valve seat    -   112 i second inlet valve seat    -   112 o second outlet valve seat    -   113 a first chamber cavity    -   113 b second chamber cavity    -   114 a surface of first chamber cavity 113 a    -   114 b surface of second chamber cavity 113 b    -   115 a inclined region of first pump chamber 113 a    -   115 b inclined region of second pump chamber cavity 113 b    -   116 a rim of first pump chamber 113 a    -   116 b rim of second pump chamber cavity 113 b    -   117 a perimeter of first pump chamber cavity 113 a    -   117 b perimeter of second pump chamber cavity 113 b    -   118 i perimeter of first inlet valve seat 111 i    -   118 o perimeter of first outlet valve seat 111 o    -   119 i perimeter of second inlet valve seat 112 i    -   119 o perimeter of second outlet valve seat 112 o    -   121 i groove of first inlet valve seat 111 i    -   1210 groove of first outlet valve seat 111 o    -   122 i groove of second inlet valve seat 112 i    -   122 o groove of second outlet valve seat 112 o    -   131 i first inlet valve portal for fluid communication between        inlet channel 138 i and first inlet valve seat 111 i    -   131 o first outlet valve portal for fluid communication between        first outlet valve seat 111 o and outlet channel 138 o    -   132 i second inlet valve portal for fluid communication between        inlet channel 138 i and second inlet valve seat 112 i    -   132 o second outlet valve portal for fluid communication between        second outlet valve seat 112 o and outlet channel 138 o    -   133 i chamber channel for fluid communication between first        chamber cavity 113 a and first inlet valve seat 111 i    -   133 o chamber channel for fluid communication between first        chamber cavity 113 a and first outlet valve seat 111 o    -   134 i chamber channel for fluid communication between second        chamber cavity 113 b and second inlet valve seat 112 i    -   134 o chamber channel for fluid communication between second        chamber cavity 113 b and second outlet valve seat 112 o    -   135 i seat rim of first inlet valve seat 111 i    -   135 o seat rim of first outlet valve seat 111 o    -   136 i seat rim of second inlet valve seat 112 i    -   136 o seat rim of second outlet valve seat 112 o    -   138 i inlet channel    -   138 o outlet channel    -   139 i bypass channel between inlet channel 138 i and first pump        chamber    -   103 a    -   139 o bypass channel between first pump chamber 103 a and outlet        channel 138 o    -   140 a&b chamber diaphragms    -   141 a first pump chamber diaphragm region of chamber diaphragms        140 a, b    -   141 b second pump chamber diaphragm region of chamber diaphragms        140 a, b    -   142 a-f holes in chamber diaphragm for assembly    -   150 a&b valve diaphragms    -   151 i first inlet valve region of valve diaphragms 150 a&b    -   151 o first outlet valve region of valve diaphragms 150 a&b    -   152 i second inlet valve region of valve diaphragms 150 a&b    -   152 o second outlet valve region of valve diaphragms 150 a&b    -   160 chamber plate    -   161 a first chamber actuation cavity    -   161 b second chamber actuation cavity    -   162 a&b air transfer bosses    -   163 a passage between opening 164 a and boss 162 a    -   163 b passage between opening 164 b and boss 162 b    -   164 a opening between first chamber cavity 161 a and passage 163        a    -   164 b opening between second chamber cavity 161 b and passage        163 b    -   165 a&b cavity surface 166 a&b    -   166 a&b recess    -   166 c&d inclined regions    -   167 a&b rims    -   168 a&b perimeters    -   169 a-d assembly posts    -   170 valve plate    -   171 i actuation cavity of first inlet valve 101 i    -   171 o actuation cavity of first outlet valve 101 o    -   172 i actuation cavity of second inlet valve 102 i    -   172 o actuation cavity of second outlet valve 102 o    -   173 i passage between actuation cavity 171 i of first inlet        valve 101 i and boss 176 a    -   173 o passage between actuation cavity 171 o of first outlet        valve 101 o and boss 176 b    -   174 i passage between actuation cavity 172 i of second inlet        valve 102 i and boss 176 c    -   174 o passage between actuation cavity 172 o of second outlet        valve 102 o and boss 176 d    -   175 mounting hook    -   175 a opening defined by mounting hook    -   176 a-d air transfer bosses    -   177 i groove for o-ring 192 a    -   177 o groove for o-ring 192 b    -   178 i groove for o-ring 192 c    -   178 o groove for o-ring 192 d    -   179 a-f assembly holes    -   180 i inlet line    -   180 o outlet line    -   190 manifold cover plate    -   192 a-d valve o-rings    -   193 a&b chamber o-rings    -   210 motive fluid valve    -   212 valve controller    -   220 pressure source    -   230 vacuum source    -   238 fluid source or blood uptake    -   239 fluid return, receiver, or destination    -   300 forming fixture    -   310 first plate    -   311 a&b chamber region recess    -   312 a&b o-ring groove    -   313 a&b openings between forming recess 311 a, b and vacuum port        318    -   314 a&b surface of recess    -   318 vacuum port or passage    -   320 second plate    -   321 a&b heating windows or portals    -   330 heater    -   331 heater surface    -   400 manifold mounting assembly    -   402 a&b manifold covers    -   403 a&b mounting latches    -   406 catch    -   407 motive fluid transfer boss    -   410 manifold base    -   411 motive fluid transfer boss    -   412 motive fluid transfer boss    -   413 motive fluid transfer boss    -   414 motive fluid transfer boss    -   415 motive fluid transfer boss    -   416 motive fluid transfer boss    -   417 transfer passage of manifold between air transfer bosses        412, 413, 414 and portal B    -   418 transfer passage of manifold between air transfer bosses        411, 415, 416 and portal A    -   421 flow restriction between air transfer boss 412 and transfer        passage 418    -   422 flow restriction between air transfer boss 415 and transfer        passage 417    -   431 a-f o-rings    -   432 a&b screws    -   433 a&b washers    -   434 a-d screws    -   435 a&b brackets    -   436 a-d fasteners    -   450 pump assembly    -   451 pump control system    -   452 processor    -   453 user control interface    -   454 enclosure    -   700 cardiopulmonary by-pass system    -   701 oxygenator    -   702 arterial tubing segment    -   703 arterial cannula    -   704 venous return catheter    -   705 venous tubing segment    -   706 reservoir    -   709 cardioplegia cannula    -   711 medical fluid bag    -   712 vent catheter    -   713 suction device    -   750 heart-assist system    -   753 cannula or attachment to vascular system on venous side    -   754 cannula or attachment to vascular system on arterial side    -   800 extracorporeal circuit    -   802 tubing segment on blood uptake from patient vascular system    -   803 drip chamber    -   804 a&b pressure transducers    -   805 tubing segment    -   807 tubing segment    -   808 heparin pump    -   810 dialyzer    -   811 tubing segment    -   812 drip chamber    -   814 tubing segment on blood return to patient vascular system    -   820 dialyzing liquid system    -   825 air detector    -   1100 pump    -   1101 i first inlet valve    -   1101 o first outlet valve    -   1103 a first pump chamber    -   1110 pump body    -   1133 i chamber channel between first inlet valve and first pump        chamber    -   1133 o chamber channel between first pump chamber and first        outlet valve    -   1135 i rim of first inlet valve    -   1135 o rim of first outlet valve    -   1138 i inlet channel    -   1138 o outlet channel    -   1140 one or more diaphragms    -   1141 a diaphragm actuation region of first pump chamber    -   1151 i diaphragm actuation region of first inlet valve    -   1151 o diaphragm actuation region of first outlet valve    -   1160 chamber plate    -   1162 a motive fluid transfer boss    -   1163 a motive fluid passage    -   1173 i motive fluid passage    -   1173 o motive fluid passage    -   1176 a motive fluid transfer boss    -   1176 b motive fluid transfer boss    -   1180 i inlet line    -   1180 o outlet line    -   A first supply port connection between air valve 210 and        manifold plate 400    -   B second supply port connection between air valve 210 and        manifold plate 400    -   P patient

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

This disclosure relates to a pump apparatus and related methods andsystems. Various views of an illustrative embodiment of a pump areprovided in FIGS. 1-6B and 9A-11. FIGS. 7-8B relate to an embodiment ofa forming fixture used to shape regions of a chamber diaphragm which canbe used in a pump. An embodiment of pumping system utilizing a doublediaphragm pump is shown in FIGS. 12-15. FIG. 16 provides a schematicview of an embodiment of a system utilizing a double diaphragm pump. Theschematic views provided in FIGS. 17-19 illustrate various applicationsof embodiments of double diaphragm pumps in medical applications inwhich blood is pumped.

It is noted that similar or duplicate features are referred to with aunique alphanumeric designation. Certain features common to variousembodiments may be designated with a primed numeral in some figures. Ineither case, duplicate elements will not be described in further detailto the extent their performance is similar to the embodiments previouslydescribed. For example, the chamber diaphragms illustrated in FIG. 2will be referred to as 140 a and 140 b, and various diaphragm bloodpumps are referred to in FIG. 17 as 100 b, 100 c, 100 d, etc. A pumpbody in one embodiment is referred to in FIG. 9C as 110 and a pump bodyin another embodiment is referred to in FIG. 10 as 110′.

Certain diaphragm pumps can have application as a single use disposablemedical blood pump. For example, a pump can be used to move bloodthrough an extracorporeal circuit. An advantage of pumping blood withcertain pumps as described herein is that, in various embodiments, arelatively small amount, a minimal amount, a negligible amount, or evenno amount of synthetic pump material particles is released into the flowof blood that is caused by rubbing, sliding, or straining of materialstypically used in other types of pump mechanisms to energize fluid flow.Synthetic particulates generated by certain pumps that move fluids toand from a patient have the potential to create adverse health effectsincluding embolisms or microembolisms in the vascular system. Further,the toxicity of materials introduced or generated by such pumps can bedelivered to the patient and can be left residing in the vascular systemof the patient.

Certain embodiments of a pneumatically actuated diaphragm pump can beadvantageous because of the inherent control that may be achieved fordelivering fluids within physiologically acceptable pressure ranges. Forexample, if a blockage occurs in the process fluid lines connected to anembodiment of a pump, some embodiments of the pump may only generatepressure in the process fluid at a level that is at or near those of themotive fluid pressures that are driving the pump. In the case of pumpingblood, such a pump can reduce or eliminate excessive pressures or highvacuums in the fluid lines that can potentially damage blood or causeair embolisms by out-gassing the blood under high suction levels.

Some embodiments of pumping systems that may be used in single-usedisposable medical applications can advantageously be comprised of aremovable and/or separable disposable pumping component and a reusablepump control system. The disposable pumping component can be packagedand pre-sterilized for use in a medical application related to anindividual patient. In some embodiments, the disposable pumpingcomponent can be coupled in operative association with the reusable pumpcontrol system for a single patient during a medical application, andthen removed and disposed.

In some embodiments, the reusable pump control system can be isolatedfrom the flow of biological fluids and may selectively control andoperate a plurality of disposable pumping components—one or more foreach of a multiple number of patients or applications, in someinstances—without being sterilized between uses. Theremovable/disposable pumping component may include pump chambers, inletand outlet valves, inlet and outlet lines, and other components whichare in contact with the blood or biological fluid. In some embodiments,the removable/disposable pumping component comprises a double diaphragmpump. As discussed below, in some embodiments, the double diaphragm pumpcan be configured and designed with a plurality of pump chambers, flowpaths, valves, etc. that are specifically designed for a particularapplication. For example, some embodiments of double diaphragm pumps canbe configured for use in such medical applications as cardiopulmonarybypass, surgical perfusion support, heart assist, and hemodialysis, asfurther described below.

Various embodiments of double diaphragm pumps also enable fluids to betransferred in a wide variety of other fields. For example, such pumpscan be used in the transfer of high purity process fluids. Someembodiments of double diaphragm pumps can be advantageous intransferring high purity process fluids, as the pump avoids, minimizes,or otherwise reduces the introduction or generation of contaminants orparticulate matter that can be transferred downstream by reducing oreliminating rubbing and sliding components within the pump. Downstreamtransfer of contaminants or particulate matter may effect the desiredoutcome of using the high purity process fluid. Also for shear sensitivefluids, some pumps can be operated to gently move fluid from a source toa destination.

FIG. 1 provides a perspective view of an embodiment of a doublediaphragm pump at 100. The pump 100 can comprise a plurality of housingmembers or housing components, which in some embodiments may besubstantially rigid, as discussed below. In some embodiments, thehousing members comprise a pump body 110, a chamber plate 160 and avalve plate 170. In some embodiments, the pump 100 further comprises aplurality of diaphragms. For example, in some embodiments, the pump 100comprises one or more chamber diaphragms 140 a, 140 b, which can belocated between chamber plate 160 and pump body 110, and furthercomprises one or more valve diaphragms 150 a, 150 b, which can belocated between valve plate 170 and pump body 110. The chamberdiaphragms 140 a, b and valve diaphragms 150 a, b are not identified inFIG. 1 but are shown in FIGS. 2, 9B, and 9C. While these diaphragms maynot necessarily extend to the perimeter of pump body 110, chamber plate160, or valve plate 170, in some embodiments, the media can extend tothe perimeter or beyond so that the media protrudes beyond an outer edgeof the pump body 110. As further discussed below, in some embodiments,manifold cover plate 190 seals or closes motive fluid passages definedby chamber plate 160.

FIG. 1 and FIG. 4 show features related to the inlet and outlet linesfor the passage of process fluid through the pump body 110. Inparticular, inlet line 180 i is connected with inlet channel 138 i andoutlet line 180 o is connected with outlet channel 1380, as shown. Inletchannel 138 i and outlet channel 138 o are shown in more detail in FIG.4, FIGS. 9B-10 and FIG. 16. In the embodiment illustrated in FIGS. 1 and4, representative connections between inlet line 180 i and inlet channel138 i and between outlet line 180 o and outlet channel 138 o are shown.Similar connections can be made to other external fluid lines ordevices. The connection between these components can include solventbonding, adhesives, mechanical fittings (including barbed nipple tubefittings), or other methods well known in the art.

Some of the components which comprise the valves and the pump chambersare shown in FIG. 2, however, the valves and the pump chambers are notidentified in FIG. 2, as this figure represents an exploded perspectiveview of a double diaphragm pump 100. As illustrated in FIGS. 9B-9C andFIG. 10, certain embodiments of the double diaphragm pump 100 cancomprise a first inlet valve 101 i, first outlet valve 101 o, secondinlet valve 102 i, second outlet valve 1020, first pump chamber 103 a,and second pump chamber 103 b. FIG. 2 also shows a plurality of valveseals or o-rings 192 a-d and chamber seals or o-rings 193 a, b, whichcan be used in some embodiments to assist in sealing valves and pumpchambers. For example, in some embodiments, the valve plate 170comprises grooves 177 i, 177 o, 178 i, and 1780 (see FIG. 3) forreceiving o-rings 192 a-d. Similarly, chamber plate 160 can comprisegrooves for receiving o-rings 193 a, b.

Other means of sealing the valves and chambers can also be used,including adhesives, heat bonding, and welding. In certain embodiments,the diaphragms 140 a, b and 150 a, b and pump body 110 can be fabricatedwith similar materials that will bond together when heated. In someembodiments, fluorinated ethylene propylene (FEP) materials can be usedfor both of the diaphragms 140 a, b, 150 a, b and the pump body 110, andheat can be used to bond the diaphragms to the body. Other heat sealablematerials that can be used for both of the diaphragms 140 a, b, 150 a, band the pump body 110 include polyvinylchloride (PVC), polyurethane(PU), and polypropylene (PP). In some embodiments, an adhesive, such asScotch Weld Acrylic DP-8005 adhesive manufactured by 3M—IndustrialBusiness, Industrial Adhesives and Tapes Division, St. Paul, Minn., isused to attach the chamber plate 160 assembly posts 169 a-d and airbosses 162 a, b (see, e.g., FIG. 5) to the valve plate 170 assemblyholes 179 a-f (see, e.g., FIG. 3). Components of a double diaphragm pump100, such as the components shown in FIG. 2 can be assembled together inany other suitable manner, such as via mechanical fasteners (for examplenuts and bolts, clamps, screws, etc.); adhesives; welding; bonding; orother mechanisms. These mechanisms are all examples of means formaintaining the plates and body together and sealing chambers createdbetween the plates and body.

FIG. 2 provides the best view of the chamber diaphragms 140 a, b andvalve diaphragms 150 a, b. In the illustrated embodiment, each diaphragm140 a, b and 150 a, b has a specific region corresponding with aparticular chamber. In some embodiments, the regions are preformed orpre-shaped prior to assembly of the pump 100. In some embodiments, asingle diaphragm is used between pump body 110 and chamber plate 160and/or a single diaphragm is used between pump body 110 and valve plate170. In other embodiments, two or more diaphragms are utilized betweenone or more sets of neighboring components, which can provide a pump 100with one or more redundant layers for safety purposes. For example, inthe unlikely event that one of the diaphragms were to fail due to a raremanufacturing defect, interaction with a sharp object in the air orfluid flow, cyclic fatigue cracking, or other cause of failure, the pumpcould safely operate using a redundant diaphragm. In some embodiments,each chamber or valve uses a separate diaphragm or diaphragms that arenot integrated into a multi-chamber diaphragm. Additionally, theseparate diaphragms can also include preformed or pre-shaped actuationregions. In some embodiments, the actuation regions are configured tomove between a natural shape and an inversion of the natural shapewithout significant stretching, as further discussed below. Theactuation regions can be configured to flex, in some embodiments.Methods for forming diaphragms with pre-shaped regions are discussedbelow with reference to FIGS. 6A, 6B, 7, 8A, and 8B.

In certain embodiments, the preformed actuation regions of chamberdiaphragm 140 a include first pump chamber region 141 a and second pumpchamber region 141 b. The preformed actuation regions of valve diaphragm150 a include first inlet valve region 151 i, first outlet valve region151 o, second inlet valve region 152 i, and second outlet valve region152 o. Each media 140 a, b and 150 a, b can also have holes 142 a-f (seeFIG. 6A) for manufacturing and assembly, as further discussed below.

With reference to FIGS. 2, 9B, and 9C, first pump chamber 103 a isdivided by first pump chamber region 141 a into first pump chambercavity 113 a and first actuation cavity 161 a. Similarly, second pumpchamber 103 b is divided by second pump chamber region 141 b into secondpump chamber cavity 113 b and second actuation cavity 161 b. Each of thevalves 101 i, 101 o, 102 i, and 102 o is also divided by its respectivediaphragm regions. In particular, each of valves 101 i, 101 o, 102 i and102 o comprises an actuation cavity and a valve seat. The valve seatsinclude first inlet valve seat 111 i, first outlet valve seat 111 o,second inlet valve seat 112 i, and second outlet valve seat 112 o. Theactuation cavities include actuation cavity 171 i of first inlet valve101 i, actuation cavity 171 o of first outlet valve 101 o, actuationcavity 172 i of second inlet valve 102 i and actuation cavity 172 o ofsecond outlet valve 102 o. Together, a given valve seat/actuation cavitypair can define a valve chamber through which a diaphragm region canmove. For example, with reference to FIG. 9B, the first outlet valveregion 151 o can move within a valve chamber that is comprised of thefirst outlet valve seat 111 o and the actuation cavity 171 o.

The flow paths of the process fluid in some embodiments of the doublediaphragm pump 100 are described below with reference to FIG. 4 and FIG.16. The flow path is also described with reference to FIGS. 9A-10.Before providing a comprehensive overview of the flow path, thecomponents of double diaphragm pump 100 are described below withoccasional reference to the flow path. However, it should be understoodthat a process fluid is pumped into and out of first pump chamber 103 aand second pump chamber 103 b so that the process fluid enters and exitspump body 110. It should also be understood that the different regionsof the diaphragm media are moved by alternating applications of pressureand vacuum to the pump chambers and valves to pump the process fluidinto and out of pump chambers 103 a and 103 b and allow or prevent flowthrough valves 101 i, 101 o, 102 i, and 102 o. The pressure and vacuumcan be provided by one or more fluids (also referred to as motivefluids) at differing pressure levels. In many embodiments, the motivefluids used with a pump 100 comprise air. Accordingly, referencethroughout this disclosure may be made to “air” when describing themovement of motive fluid or when describing components associated withand/or that contact motive fluid during operation of a pump 100. Suchreferences are not intended to be limiting, but rather, are made only tofacilitate the discussion herein. For any such reference, other suitablefluids are also possible, such as, for example one or more liquidsand/or gases.

In certain embodiments, different regions of the chamber diaphragms 140a and 140 b and valve diaphragms 150 a and 150 b can be moved byapplying pressure of the motive fluid which is greater than the pressureof the process fluid at the process fluid destination, receiver, orreturn 239 (see FIG. 16) and alternating with application of pressure ofthe motive fluid which is less than the pressure of the process fluid atthe process fluid source 238 (see FIG. 16).

The amount of pressure or vacuum applied can vary significantlydepending on the intended use of the pump 100. For example, in someembodiments, the double diaphragm pump 100 delivers a fluid at apressure in a range of between about 0 mmHg (millimeters of mercury) andabout 1500 mmHg, between about 50 mmHg and about 500 mmHg, between about50 mmHg and about 700 mmHg, or between about 80 mmHg and about 500 mmHg.Similarly, in some embodiments, the double diaphragm pump 100 mayreceive fluid from a source or generate suction in a range of betweenabout −500 mmHg and about 0 mmHg, between about −250 mmHg and about 0mmHg, between about −120 mmHg and about 0 mmHg, or at an amount that isless than the fluid pressure at the process fluid source 238.

In some embodiments of the double diaphragm pump 100 that are configuredto be used as a blood pump, blood is received into the pump anddelivered from the pump in a range between about −250 mmHg and about 500mmHg. While blood pressure in a patient vasculature system is typicallyin a range of 0 mmHg to 200 mmHg, depending on the location of blood inthe system and condition of the patient, the blood pump 100 may operateat higher pressures and with vacuum assisted suction to overcomepressure losses in the extracorporeal circuit. These pressure losses canoccur as blood flows through cannulae, connection lines, blood treatmentdevices, filters, reservoirs, and connectors. The blood pump may beoperated to cause the blood to be drawn from and return to the patientvascular system at safe levels. These safe levels of blood pressure atthe fluid source 238 may be above 0 mmHg and the blood pressure at thefluid return 239 may be below 150 mmHg. The blood may also be drawn intothe pump without a vacuum source supplied to the pump (e.g., byapplication of about 0 mmHg relative pressure via a vacuum source orvent 230). Gravity feed into the pump may also be used to assist infilling the pump chambers. For example, in some embodiments, the processfluid source 238 is at an elevated pressure and at an elevated locationfrom the pump and the resultant blood pressure at the pump causes thepump valves and chambers to vent the motive fluid and actuate thediaphragms when the pressure source 220 is removed (e.g., about 20 mmHgrelative to atmosphere and located 24 inches higher in elevation). Amotive fluid at a pressure higher than the elevated pressure of theblood entering the pump and also higher than the pressure at the fluidreturn 239 can be used to operate the pump and expel the process fluidfrom the pump 100 to deliver blood through an external circuit to theprocess fluid return 239 at acceptable physiological pressures (e.g., insome cases at about an average pressure of 80 mmHg).

FIG. 3 and FIGS. 9B-9C show actuation cavity 171 i of first inlet valve102 i, actuation cavity 171 o of first outlet valve 102 o, actuationcavity 172 i of second inlet valve 102 i, and actuation cavity 172 o ofsecond outlet valve 102 o. Passages 173 i, 173 o, 174 i, and 174 oprovide fluid communication to the actuation cavities through the airtransfer bosses 176 a-d. The air transfer bosses 176 a-d may also bereferred to as connections, connectors, posts, protrusions, interfaces,passageways. These terms can also be used to describe other bossesdescribed herein.

FIG. 5 shows the chamber plate 160, which can include first chamberactuation cavity 161 a and second chamber actuation cavity 161 b. Thechamber plate 160 can include passages 163 a and 163 b. As shown, forexample, in FIG. 1, the manifold plate 190 can be sealed over passages163 a and 163 b. With reference again to FIG. 5, passage 163 a providesfluid communication to actuation cavity 161 a via opening 164 a, andpassage 163 b provides fluid communication to actuation cavity 161 b viaopening 164 b.

In certain embodiments, actuation cavities 161 a, b are defined bycavity surfaces 165 a, b that extend to outer perimeters 168 a, b,respectively. The cavity surfaces 165 a, b can include recesses 166 a,b, respectively. An edge of each recess 166 a, b is shown with dashedlines in the embodiment illustrated in FIG. 5. In some embodiments, oneor more of the recesses 166 a, b are substantially rounded, and may beconcavely rounded. The cavity surfaces 165 a, b can include inclinedregions 166 c, d that extend from the recesses 166 a, b and outer rims167 a, b of the actuation cavities 161 a, b, respectively. In someembodiments, the inclined regions 166 c, d are also rounded, and may beconvexly rounded. In some embodiments, rounded recesses 166 a, b androunded inclined regions 166 c, d can limit the mechanical strain andincrease cyclic life induced by limiting the minimum radius of bendingcurvature of the integrated diaphragm media 140 a, b in the diaphragmactuation region 141 a, b between the constrained edge of the diaphragmactuation region and a slope inflection point of the diaphragm actuationregion as the diaphragm actuation region 141 a, b transitions betweenend-of-stoke positions.

FIG. 4 shows a plan view of a first face or a first side of pump body110, and illustrates first inlet valve seat 111 i, first outlet valveseat 111 o, second inlet valve seat 112 i and second outlet valve seat112 o. First pump chamber cavity 113 a and second pump chamber cavity113 b, which are located on the opposite face or side of pump body 110,are shown in phantom. Each valve seat has a groove 121 i, 121 o, 122 i,122 o around a corresponding rim 135 i, 135 o, 136 i, 136 o. A valveportal 131 i, 131 o, 132 i, 132 o provides fluid communication betweeneach valve seat and its corresponding line. For example, inlet channel138 i, which is shown in phantom, is in fluid communication with firstinlet valve portal 131 i and second inlet valve portal 132 i. Similarly,outlet channel 138 o, which is also partially shown in phantom andpartially shown in the broken section view, is in fluid communicationwith first outlet valve portal 131 o and second outlet valve portal 132o.

Chamber passages or channels 133 i and 133 o provide fluid communicationrespectively between first inlet valve seat 111 i and first pump chambercavity 113 a and between first outlet valve seat 111 o and first pumpchamber cavity 113 a. Similarly fluid communication between second inletvalve seat 112 i and second pump chamber cavity 113 b and between secondoutlet valve seat 112 o and second pump chamber cavity 113 b isachieved, respectively, via chamber channels 134 i and 134 o. Thisconfiguration permits first inlet valve seat 111 i and second inletvalve seat 112 i to be in fluid communication with inlet channel 138 iand to alternatively receive process fluid. Similarly, first outletvalve seat 111 o and second outlet valve seat 112 o are in fluidcommunication with outlet channel 138 o and alternatively deliverprocess fluid.

FIG. 4 also shows other features of the pump chamber cavities 113 a and113 b. Surfaces of each pump chamber cavity, which can be recessedsurfaces, are identified respectively at 114 a and 114 b with aninclined region for each identified at 115 a and 115 b, respectively. Arim 116 a, b and a perimeter 117 a, b are also identified for each ofthe pump chamber cavities 113 a, b, respectively. The perimeters of thevalve seats are also shown in FIG. 4. The perimeter of first inlet valveseat 111 i and the first outlet valve seat 111 o are respectively shownin phantom and identified as 118 i and 118 o. The perimeter of secondinlet valve seat 112 i and the second outlet valve seat 112 o arerespectively identified at 119 i and 119 o.

With continued reference to FIG. 4 and, additionally, with reference toFIGS. 9B and 9C, in certain embodiments, the pump chamber cavities 113a, b can define a smooth transition from a face of the pump body 110 tothe recessed surfaces 114 a, b. For example, in some embodiments, theperimeters 117 a, b of the pump chamber cavities 113 a, b are located ata substantially planar face of the pump body 110. The rims 116 a, b canbe substantially rounded, and can provide a smooth transition from theplanar face at the perimeters 117 a, b to the inclined regions 115 a, b.

Similarly, the valve seats 111 i, 111 o, 112 i, 112 o can define asmooth transition from a face of the pump body 110 to a more recessedportion of the pump body 110. For example, the valve seat 111 i cansmoothly slope inward from the perimeter 118 i, which can be at asubstantially planar first face of the pump body 110, toward a morerecessed portion of the valve seat 111 i that is closer to an oppositeface of the pump body 110.

In certain embodiments, smooth, tangent, or rounded transitions such asjust described can limit the mechanical strain by limiting the minimumradius of bending curvature of the diaphragm actuation region betweenthe constrained perimeter of the diaphragm and a slope inflection pointin the diaphragm as the diaphragm actuation region transitions betweenend-of-stoke positions. Reduced mechanical strain can result in a longerlifespan of the chamber diaphragms 140 a, b and valve diaphragms 150 a,b, in certain embodiments. In some embodiments, the diaphragms areconstrained to flex at the smooth or rounded transitions (e.g., to flexover the rounded lips 116 a, b). In some embodiments, the amount ofstrain induced in a flexing diaphragm is inversely related to the radiusof curvature in these regions; as a result, longer mechanical life ofthe diaphragms can be achieved with relatively gradually slopingtransition regions. In other embodiments, relatively sharp transitionsin these regions can cause the diaphragm to flex across a plastic-likehinge. A diaphragm actuation region could incur high cyclic strain incertain of such embodiments, and might rapidly fail due to cyclicfatigue.

The valve diaphragms 150 a, 150 b can have additional support as thediaphragms rest on seat rims 135 i, 135 o, 136 i, and 136 o in a closedvalve position, which can be at a position near a preformed dome heightof the valve diaphragm valve regions 151 i, 151 o, 152 i, 152 o. If thediaphragm material is too stretchable or if the diaphragm valve regions151 i, 151 o, 152 i, 152 o are formed with excessive dome heights, highstrain plastic-like hinges can form on the edges of the seat rims, andmay cause high cyclic strain and short cyclic fatigue life. In someembodiments, the diaphragm valves desirably actuate from an open to aclosed position at a differential pressure less than that provided bythe pressure source 220 and at a differential pressure level less (e.g.,less negative) than that provided by the vacuum source 230 (see FIG.16). This can allow the valves to quickly open and close prior to thepump chamber causing a substantial amount of process fluid to flow backthrough the closing valves.

In some embodiments, chamber diaphragms 140 a, b and valve diaphragms150 a, b have actuation regions, which are pre-shaped or formed prior toassembly of the pump 100, as further discussed below. The actuationregions can protrude from a plane defined by a relatively flat portionof a diaphragm 140 a, b, in some embodiments. In further embodiments,the actuation regions naturally protrude and/or are naturally rounded ina convex manner when in a first state or resting state, and can betransitioned to a concave orientation when in a second state ordisplaced state. The second state can be stable or metastable, in someembodiments, and the actuation regions can define a variety of othershapes in the first and/or the second states. In some embodiments, theactuation regions can be readily transitioned between the first andsecond states, and the regions can deform, flex, or otherwise changeshape by application of a relatively small amount of pressure, ascompared with a substantially flat diaphragm without actuation regionswhich is stretched to conform to the same shape of the first or secondstate of an actuation region.

FIG. 6B depicts chamber diaphragm 140 a after the formation of firstpump chamber region 141 a and second pump chamber region 141 b.Preforming the chamber regions 141 a, b of the chamber diaphragms 150 a,b and the valve regions 151 i, 151 o, 152 i, 152 o of the valvediaphragms 140 a, b can enable the valve regions to be seated and thechamber regions to move fluid into and out of the chambers based only onsufficient pressure (positive or negative) for movement of the regions,in some arrangements. Stated otherwise, after these regions of thediaphragm film material have been formed by, for example, heat formingor stretching, the regions can move in response to fluid pressure withlow strain as each valve or chamber cycles like a fluid isolatingmembrane.

In some embodiments, the diaphragm regions are preformed in such amanner that the cord length of the valve regions and the chamber regionsremains substantially constant while cycling. In other embodiments, thediaphragm regions stretch by a relatively small amount. One method toquantify diaphragm stretch is the change in cord length as the diaphragmflexes from end-of-stroke positions, where the cord length is the lengthof a cord if positioned on the surface of the diaphragm such that thecord extends from one point on the perimeter of the formed region andcontinues through the center point of the region to a second point onthe perimeter of the formed region, with the first and second pointsbeing opposite from each other relative to the center point. Forexample, in various embodiments, the cord length can change by less thanabout 10%, less than about 5%, or less than about 3% during each pumpcycle. The cord length can be sufficient to enable the diaphragm regions150 a, b and 151 i, 151 o, 152 i, 152 o to flex and pump the fluid inthe pump chamber and to flex and controllably seal the fluid flowthrough the pump valves at the same or substantially the same pressures.By preforming the regions of the diaphragm media in some embodiments,the valve regions can be seated without application of additionalpressure, as compared with the pressure used to move the region of thediaphragm within the pump chamber. By controlling the cord length of adiaphragm in certain embodiments, the mechanical cycle life of thediaphragm can be increased by minimizing material strain when flexingfrom one end-of-stroke condition to the other end-of-stroke condition,and the diaphragm can be capable of reaching the end-of-stroke conditionwithout (or substantially without) the material of the diaphragmstretching. In certain embodiments, since pressure is applied formovement or is applied for movement and at most a nominal amount forstretching the preformed actuation regions, the amount of pressureneeded to actuate the diaphragm region is low and the lifespan of thediaphragm media is extended due to the gentler cycling. In someembodiments, since material strain is reduced using thin film materialsin the construction of the flexing chamber diaphragms 140 a, b and valvediaphragms 150 a, b, the material strain caused by in-plane stretchingcan be controlled by the support of the pump chamber and valve cavitiesat end-of-stroke conditions, and long mechanical life of the diaphragmscan be achieved.

In certain embodiments, higher ratios of the maximum distance betweenopposing sides of a perimeter or perimeter width (e.g., the diameter ofa circumference) of a diaphragm region 141 a, b, 151 i, 151 o, 152 i,152 o to a dome height of the region can promote long mechanical cycliclife of the diaphragms 140 a, b, 150 a, b without material fatiguefailure. In some embodiments, the dome height of a region is defined asthe maximum distance from a plane defined by a maximum perimeter of theregion (e.g., a maximum circumference of the region) to any portion ofthe diaphragm material that comprises the region along a line normal tothe plane. The term “dome height” is a broad term and is not limited tosituations in which an actuation region 141 a, b, 151 i, 151 o, 152 i,152 o shaped substantially as a rounded dome. For example, a regionhaving a substantially pyramidal configuration could also define a domeheight.

In some embodiments, the diaphragm media is reshaped when travelingbetween end-of-stroke positions and the reshaping can cause the materialto strain. With relatively low ratios between the perimeter width andthe dome height of a region, the diaphragm material in some embodimentscreates relatively sharp folds in order for the dome to move from oneend-of-stroke condition to another which can cause relatively highmaterial strain and a relatively short mechanical life for thediaphragm. With relatively high ratios between the perimeter width andthe dome height of a region, the size of some embodiments of the doublediaphragm pump 100 can be relatively large, which can increase materialcosts and other costs for manufacturing the pump 100.

In various embodiments, the ratio of the perimeter width to the domeheight of the actuation regions 141 a, b of the chamber diaphragms 140a, b is between 4:1 and about 30:1, between about 5:1 and about 20:1, orbetween about 6:1 and about 10:1. In some embodiments, the ratio isabout 8:1. In certain of such embodiments, the actuation regions 141 a,b have diameters of about 2.7 inches and dome heights of about 0.36inches. For such embodiments, the actuation regions 141 a, b can have astroke volume of about 25 cubic centimeters (cc) when the dome movesfrom one end-of-stroke position to the other.

In various embodiments, the ratio of the diameter to the preformed domeheight of the actuation cavities 171 i, 171 o, 172 i, 172 o of the valvediaphragms 150 a, 150 b is between about 4:1 and about 30:1, betweenabout 5:1 and about 20:1, or between about 6:1 and about 10:1. In someembodiments, the ratio is about 8:1. In certain of such embodiments, theactuation cavities 171 i, 171 o, 172 i, 172 o have diameters of about1.12 inches and dome heights of around 0.14 inches. For suchembodiments, the actuation cavities 171 i, 171 o, 172 i, 172 o can havea valve actuation stroke volume of about 1.5 cubic centimeters (cc) whenthe dome moves from one end-of-stroke position to the other.

In certain embodiments, to actuate the chamber diaphragms 140 a, b andvalve diaphragms 150 a, b from one end-of-stroke position to another, acertain pressure differential level between the fluid on one side of adiaphragm and the actuation chamber pressure on the other side of thediaphragm is provided to overcome the structural stiffness of thediaphragms. If the structural stiffness of the diaphragms is too high,the pressure used to actuate the regions 141 a, b, 151 i, 151 o, 152 i,152 o may exceed the desired operating pressure of the pump. However,some embodiments also benefit from the structural stiffness of thediaphragms not being too low. For example, in some embodiments, thediaphragms desirably have enough structural rigidity to not plasticallydeform under the operating pressures and also to bridge over regions ofthe diaphragms that are not supported at their end-of-stoke positions.

In various embodiments, the differential pressure used to actuate thechamber diaphragms 140 a, 140 b and valve diaphragms 150 a, 150 b is ina range of between about 5 mmHg and about 200 mmHg, between about 20mmHg and about 100 mmHg, or between about 30 mmHg and about 60 mmHg. Insome embodiments, a relatively small initial pressure differential issufficient to actuate preformed regions 141 a, b, from a firstend-of-stroke position to a second end-of-stroke position. In someembodiments, a relatively small initial pressure differential issufficient to actuate preformed regions 151 i, 151 o, 152 i, 152 o froman open valve position to a closed valve position.

Once a valve is in the closed position, the valve can remain in theclosed position so long as the fluid pressure that acts on one side ofthe associated region to maintain the valve in the closed positionexceeds the fluid pressure on the opposite side of the region by anamount greater than the amount of pressure required to actuate thevalve. For example, in some embodiments, the region 151 o can beactuated from the closed valve position illustrated in FIG. 9B to anopen valve position when the pressure in the first chamber cavity 113 aexceeds the pressure in the actuation cavity 171 o by an amount greaterthan the pressure required to move the region 151 o out of the closedorientation. In various embodiments, a valve can be maintained in theclosed position when a differential pressure on opposite sides of adiaphragm actuation region is less than about 300 mmHg, less than about200 mmHg, less than about 100 mmHg, less than about 50 mmHg, less thanabout 25 mmHg, less than about 10 mmHg, less than about 10 mmHg, or isabout 0 mmHg. Similarly, in various embodiments, a valve can bemaintained in the open position when a differential pressure on oppositesides of a diaphragm actuation region is less than about 300 mmHg, lessthan about 200 mmHg, less than about 100 mmHg, less than about 50 mmHg,less than about 25 mmHg, less than about 10 mmHg, less than about 10mmHg, or is about 0 mmHg.

Some embodiments can include diaphragms 140 a, b, 150 a, b that compriseelastomeric material in a flat sheet configuration. Certain of suchembodiments, however, can exhibit performance characteristics that arenot present or are much less pronounced in some embodiments that includediaphragms 140 a, b, 150 a, b having actuation regions 141 a, b, 151 i,151 o, 152 i, 152 o. For example, in some embodiments having a flatsheet configuration, operation of the pump can cause repeated in-planestretching of diaphragm material as displacement volumes are created,which can cause a diaphragm to fail as a result of low cycle, highstrain material fatigue. In some embodiments, the pressure and suctionlevels needed to stretch the material by an amount sufficient to actuatethe valves can exceed the available pressure level in the pressuresource 220 and/or the available vacuum level in the vacuum source 230(see FIG. 16). Therefore, such embodiments might employ higher levels ofpressure and vacuum to actuate the valves 101 i, 101 o, 102 i, 102 o toprevent the fluid pressures created in the pumping chambers 103 a, bfrom overcoming the valve actuation pressures.

Further, variation in fluid pressures can be created in the pumpingchambers 103 a, b during a pumping stroke. In certain embodiments thatinclude a sheet-like diaphragm without preformed actuation regions 141a, b, 151 i, 151 o, 152 i, 152 o, the diaphragm stretches to fill anddischarge fluid and uses a dynamically changing portion of the pressuresupplied to the pump chamber 103 a, b in the stretching process. Thepressure within the pump chamber as the chamber fills with fluid isrelated to the difference between the pressure supplied by a pressuresource and the changing amount of pressure used to actuate and stretchthe flat sheet diaphragm in its travel through a stroke. When the pumpchamber discharges from a filled state, energy stored in the stretcheddiaphragm releases and increases the pressure supplied to the pumpactuation chamber, which may result in pressure spikes in the outletline 180 o. In some embodiments, such pressure spikes can beundesirable. Similarly, when the pump chamber is filled from adischarged state, the energy stored in the stretched diaphragm releasesand increases the suction supplied to the pump chamber 103 a, b, whichmay result in suction spikes in the inlet line 180 i. In someembodiments, such suction spikes can be undesirable. Some embodimentsthat include actuation regions 141 a, b 151 i, 151 o, 152 i, 152 o thuscan provide inlet line 180 i and/or outlet line 180 o pressures thathave fewer spikes or fluctuations as a result of the actuation regions141 a, b, 151 i, 151 o, 152 i, 152 o transitioning between first andsecond states.

In certain embodiments, each of the diaphragms 140 a, 140 b, 150 a, 150b is formed from a film having a substantially uniform thickness. Thethickness of a diaphragm may be selected based on a variety of factors,such as the material or materials of which the diaphragm is composed,the size of the valve or chamber in which the diaphragm moves, etc. Adiaphragm can be configured to separate a motive fluid from the processfluid during all stages of a stroke cycle and can be supportedintermittently by surface features of the pump cavities (such as, forexample, the seat rims 135 i, 135 o, 136 i, 136 o of the inlet andoutlet valves 101 i, 101 o, 102 i, 102 o and/or the recesses 114 a, b,166 a, b of the pump chambers 103 a, b) when at an end of a strokecycle. Accordingly, in some embodiments, the diaphragm media thicknessis sufficiently thick to provide a substantially impermeable barrierbetween the process fluid and the motive fluid and to provide sufficientstiffness to resist substantial deformation when pressed against thesurface features of the pump cavities. In some embodiments, thediaphragm thickness is also sufficiently flexible or pliable totransition between open and closed valve positions or between filled anddischarged chamber positions with application of relatively smallpressure differentials. In some embodiments, a thin diaphragm can have alower level of mechanical strain when cycled between open and closedvalve positions or between filled and discharged chamber positions thancan a thicker diaphragm of otherwise like construction. The lower cyclicstrain of a thin diaphragm can increase the lifespan of the diaphragmbefore mechanical failure of the material. In various embodiments, thediaphragm media has a thickness in a range between about 0.001 inchesand about 0.060 inches, between about 0.002 inches and about 0.040inches, between about 0.005 inches and about 0.020 inches, or betweenabout 0.005 and about 0.010 inches.

In certain embodiments, higher ratios of minimum radius of bendingcurvature of the profile of the flexing portion of a preformed diaphragmto the diaphragm thickness may increase diaphragm cyclic life as thediaphragm transitions from one end-of-stroke position to another. Invarious embodiments, this ratio is in a range between about 5:1 andabout 100:1, between about 10:1 and about 50:1, or between about 20:1and about 30:1. In one embodiment, the diaphragm has a minimum radius ofbending curvature of 0.25 inches and a diaphragm thickness of about0.010 inches with a resulting ratio of 25:1.

FIG. 6A depicts an embodiment of a chamber diaphragm 140 before theregions 141 a, 141 b have been preformed or pre-stretched. In theillustrated embodiment, the diaphragm has been cut from a sheet of film.The diaphragm initially has a substantially uniform thickness and isthen shaped to yield preformed or pre-stretched regions. FIG. 6B depictschamber diaphragm 140 as it appears after being formed in formingfixture 300 as shown in FIGS. 7-8B. Other methods of forming actuationregions 141 a, 141 b in the diaphragm 140 are also possible, and theexample described with respect to FIGS. 7-8B is merely provided by wayof illustration.

FIGS. 7-8B depict the use of heat and vacuum to shape the regions 141 a,b of a diaphragm 140. Many combinations of pressure, vacuum, and heatcould also be used separately or together to form the regions in thediaphragms. For example, if only pressure is used, the residual stressesin the diaphragm shapes can cause the diaphragm form to change as thediaphragms are repeatedly cycled. In other embodiments, pressure is usedto form the diaphragm regions and then the diaphragms are annealed byheating. For example, in some embodiments, the chamber diaphragms 140 a,b are made of FEP film material that has a thickness of about 0.007inches and a formed region perimeter of about 2.7 inches is overformedto a dome height of about 0.72 inches under pressure, then heated toapproximately 60° C. for about 2 hours for a resulting dome height ofabout 0.36 inches. In a second example of pressure forming, in someembodiments, the chamber diaphragms 140 a, b are made of PTFE filmmaterial that has a thickness of about 0.010 inches and a formed regiondiameter of 2.7 inches is overformed to a dome height of about 0.58inches under pressure, then heated to approximately 60° C. for about 2hours for a resulting dome height of about 0.36 inches. In variousembodiments, the preformed diaphragm regions have a thickness in a rangefrom about 0.001 inches to about 0.060 inches, from about 0.002 inchesto about 0.040 inches, from about 0.005 inches to about 0.020 inches, orfrom about 0.005 to about 0.010 inches.

FIG. 7 depicts first plate 310 and second plate 320 of forming fixture300 in an exploded view. Because forming fixture 300 is shown being usedto produce a chamber diaphragm 140 (such as either of the diaphragms 140a or 140 b), the o-rings depicted include o-rings 193 a, 193 b. Firstplate 310 can include chamber region recesses 311 a, b that arecircumscribed by o-ring grooves 312 a, b. Plate 320 has portals 321 a, bto allow heat to reach areas of the diaphragm that are being formed.

FIG. 8A shows a cross-sectional view of fixture 300 with a diaphragmmedia 140 between first plate 310 and second plate 320. The fixture 300can be clamped together with mechanical fasteners or other assemblymechanisms to hold the diaphragm in position and seal the chamberscreated between the diaphragm and the chamber region recesses 311 a, b.A vacuum is placed in fluid communication with these chambers viapassage 318, which can include openings 313 a, b into the chamber regionrecesses 311 a, b, respectively.

A heater 330 (such as, for example, an infrared heater) is positioned toheat the regions of the diaphragm that are to be pre-shaped. In someembodiments, the diaphragm is substantially planar upon initialpositioning between the first plate 310 and the second plate 310. Thediaphragm film material can sag to a substantially non-planarconfiguration as it is heated and is exposed to a pressure differential,and the diaphragm material can conform to the surfaces 314 a, b (seeFIG. 8B) of the chamber region recesses 311 a, b to form first pumpchamber region 141 a and second pump chamber region 141 b. In someembodiments, the first plate 310 acts as a heat sink when regions of thediaphragm sag and come in contact therewith, and can prevent thediaphragm material from reaching a material transition temperature.Thus, in some embodiments, regions are fully formed after contact ismade between the sagging portion of the diaphragm media and the firstplate 310. FIG. 8B shows the fully formed chamber diaphragm 140 with theinfrared heater removed.

In some embodiments, the chamber diaphragms 140 a, b are made of FEPfilm material with a thickness of about 0.007 inches and assembled in aforming fixture 300 that is at a temperature of about 20° C. to about40° C. In certain of such embodiments, a vacuum of about −10 psi isapplied to passage 318 and an infrared heater 330 with a heater surface331 operating at a temperature of 315° C. is positioned substantiallyparallel to and about 1.5 inches away from the surface of the flatdiaphragm for about 1 minute. The heater is then removed. In certainembodiments, without being limited by theory, a diaphragm 140 formed viathermoforming techniques retains its shape as it is repeatedly cycled inthe pump because internal stresses in the diaphragm material arerelieved during the heat forming process.

While FIGS. 7-8B depict the forming of chamber diaphragm 140 a and 140b, a forming fixture configured uniquely to form the valve diaphragmregions and similar to forming fixture 300 can be used to form valveregions 151 i, 151 o, 152 i, and 152 o in valve diaphragms 150 a and 150b.

FIGS. 9B and 9C are transverse cross-sectional views taken along thecutting lines shown in FIG. 9A to show the operation of an embodiment offirst inlet valve chamber 101 i, first outlet valve chamber 101 o,second inlet valve chamber 102 i, second outlet valve chamber 102 o,first pump chamber 103 a, and second pump chamber 103 b. FIGS. 9B and 9Calso show the operation of first chamber diaphragm region 141 a andsecond chamber diaphragm region 141 b of chamber diaphragms 140 a, b.

FIG. 9B shows first inlet valve chamber 101 i, first outlet valvechamber 101 o, and first pump chamber 103 a at the end of a fluid drawstroke. In FIG. 9B, the first chamber diaphragm region 141 a of chamberdiaphragms 140 a, b is shown at an end-of-stroke position, wherepressure has been applied through passage 173 o to first outlet valvechamber 101 o and vacuum is supplied through passage 173 i to firstinlet valve chamber 101 i and also through passage 163 a, as identifiedin FIG. 5, to first pump chamber 103 a. Pressure in first outlet valvechamber 101 o causes outlet valve region 151 o of valve diaphragms 150 a150 b to move (e.g., flex) and rest on or in close proximity to firstoutlet valve seat rim 135 o, which in some instances can result in asubstantially fluid-tight seal. The seal thus formed can substantiallyprevent fluid communication between first pump chamber 103 a and outletchannel 138 o via chamber channel 131 o.

In some embodiments, suction in first outlet valve chamber 101 o causesfirst inlet valve region 151 i of valve diaphragms 150 a, 150 b to move(e.g., flex) away from first inlet valve seat rim 135 i, therebypermitting fluid communication between inlet channel 138 i and firstpump chamber 103 a via chamber channel 131 i. Suction provided viapassage 163 a (see FIG. 5) can simultaneously move first pump chamberregion 141 a of chamber diaphragms 140 a, b away from the pump body 110.In some embodiments, the suction can continue to move chamber region 141a after fluid communication between inlet channel 138 i and first pumpchamber 103 a has been established, and can draw process fluid into thefirst pump chamber 103 a. Process fluid can proceed through inlet line180 i (see, e.g., FIG. 1), through inlet channel 138 i, through valveportal 131 i, into first inlet valve chamber 101 i, through chamberchannel 133 i, and into first pump chamber 103 a.

FIG. 9C shows the second inlet valve chamber 102 i, second outlet valvechamber 102 o and second pump chamber 103 b at the end of a fluid expelstroke. The second chamber diaphragm region 141 b of chamber diaphragms140 a, 140 b is shown at an end-of-stroke position where pressure hasbeen applied through passage 174 i to second inlet valve chamber 101 iand through passage 164 b (see also FIG. 5) to second pump chamber 103b, and a vacuum has been supplied through passage 174 o to second outletvalve chamber 102 o. In such an arrangement, pressure in second inletvalve chamber 102 i prevents fluid communication between inlet channel138 i and second pump chamber 103 b via chamber channel 134 i and valveportal 132 i by flexing second inlet valve region 152 i of chamberdiaphragms 150 a, 150 b to rest on or in close proximity to second inletvalve seat rim 136 i. Simultaneously, suction applied to second outletvalve chamber 102 o flexes first outlet valve region 152 o of chamberdiaphragms 150 a, 150 b away from second outlet valve seat rim 136 o andallows fluid communication between second pump chamber 103 b and outletchannel 138 o via chamber channel 134 o and valve portal 132 o.Simultaneously, pressure provided to chamber 103 b continues to pushagainst second pump chamber region 141 b of chamber diaphragms 140 a,140 b and expels process fluid through chamber channel 134 o into secondoutlet valve chamber 102 o and then through valve portal 132 o intooutlet channel 138 o, which is in fluid communication with outlet line180 o.

In some embodiments, the inlet valves 101 i, 102 i actively controlingress of process fluid into the first and second pump chambers 103 a,b, and the outlet valves 101 o, 102 i actively control egress of processfluid from the first and second pump chambers 103 a, b, respectively. Asused herein, the term “actively control” means that the valves 101 i,101 o, 102 i, 102 o can be actuated without dependency on the directionof the flow of process fluid through the pump 100. For example, theactuation medium that controls the transitioning and positioning of thevalves 101 i, 101 o, 102 i, 102 o can do so independent of the reversalof flow of process fluid through the valve.

In some embodiments a preformed diaphragm region (e.g., 141 b, 152 i,152 o) defines its natural preformed shape when in an end-of-strokeposition. For example, the preformed region 152 o shown in FIG. 9C canbe in its natural state in the illustrated end-of-stroke position. Whenin another end-of-stroke position, the preformed region can define aninversion of the natural preformed shape. For example, in someembodiments, the preformed region 152 o is in its natural preformedshape when in the end-of stroke position shown in FIG. 9C, and can moveto inversion of its natural preformed shape when moved to anotherend-of-stroke position at or near the seat rim 136 o (such as theposition of preformed region 151 o shown in FIG. 9B). Alternatively, thepreformed region 152 o can be in its natural preformed shape when in anend-of-stroke position at or near the seat rim 136 o and can transitionto an inversion of the preformed shape at an opposite end-of-strokeposition.

In some embodiments, it can be desirable for a preformed diaphragmregion to be in its natural preformed shape when at an end-of-strokeposition, as this can reduce strain on the diaphragm region in certainarrangements. In other embodiments, the diaphragm region can passthrough its preformed shape before reaching an end-of-stroke position,which may, in some instances, cause the region to stretch in order toreach the end-of-stroke position. In still other embodiments, thediaphragm region may be prevented from achieving its natural preformedshape when operating within a pump chamber or valve chamber.

In some embodiments, it can be advantageous to switch from an expelstroke to a draw stroke before a diaphragm reaches an end-of-strokecondition, such as the position shown in FIG. 9C. Similarly, in someembodiments, it can be advantageous to switch from a draw stroke to anexpel stroke before a diaphragm travels to an end-of-stroke conditionsuch as that shown in FIG. 9B. In some embodiments, when the pumpchambers are alternately and repeatedly switched between a draw strokeand an expel stroke prior to the chamber diaphragms 140 a, 140 breaching an end-of-stroke position during the draw stroke, fluid flowthrough the inlet line 180 i can be substantially constant. In otherembodiments in which expel strokes allow the chamber diaphragms 140 a,140 b to reach an end-of-stroke position, the pause in displacement offluid during the duration of time at the end-of-stroke can cause apulsatile output flow in the outlet line 180 o. In some applications itcan be advantageous to balance the pump 100 to control the pump chambersto switch from a draw stroke to an expel stroke prior to the chamberdiaphragms reaching either end-of-stroke position.

FIG. 10 shows another embodiment of a double diaphragm pump 100′ shownin cross-section with a view such as that shown in FIG. 9B. In certainembodiments, the pump 100′ is configured to stall if air is drawn intothe pump 100′ along with the process fluid. In some embodiments, it canbe advantageous in blood pumping applications to cause the pump to stallif a significant air volume is drawn into the inlet channel 138 i. Suchair intake could be due, in some rare instances, to negative suction inthe inlet line that entrains air through a leak in a fitting or, inother rare instances, at the connection to a patient or by inadvertenterror by the practitioners. The pump body 110′ can include bypasschannels 139 i, 139 o that allow continuous or uninterrupted fluidcommunication between the inlet channel 138 i and the first pumpingchamber 103 a and between the first pumping chamber 103 a and the outletchannel 138 o, respectively. For example, in the illustrated embodiment,although the diaphragm 150 a forms a seal with seat rim 135 o, fluidcommunication is still possible between the first pumping chamber 103 aand the outlet channel 138 o because the bypass channel 139 o provides afluid path from the pumping chamber 103 a to the groove 121 o, which isin fluid communication with the outlet channel 138 o (compare FIG. 4).The pump body 110′ can include similar bypass channels that providecontinuous or uninterrupted fluid communication between the inletchannel 138 i and the second pumping chamber 103 b and between thesecond pumping chamber 103 b and the outlet channel 1380.

The bypass channels 139 i, 139 o can have flow areas that are muchsmaller than those defined by the valve portals 131 i, 131 o and chamberchannels 133 i, 133 o. A volume of air can flow through an opening at afaster rate than a like volume of liquid. Accordingly, in the event of asignificant volume of air being introduced into inlet channel 138 ialong with process fluid, the double diaphragm pump 100 will causeliquid to flow less efficiently through the pump, and air will fill thepump chambers 103 a, 103 b through the bypass channels 139 i, 139 o andthen return back through the bypass channels and may prevent continuallyexpelling air into the outlet channel 138 o and then into the outletline 180 o.

For example, in some embodiments, a mixture of process fluid and air mayenter the first chamber 103 a from the inlet channel 138 i during afluid draw stroke. As the diaphragms 140 a, b move toward the pump body110′ to decrease the volume of the chamber 103 a during an expel stroke,air within the chamber 103 a may preferentially exit the chamber 103 avia the bypass channel 139 i and return to inlet channel 138 i. Thisair, and possibly additional air received via the inlet channel 138 i,may gather or collect in the chamber 103 a and may cycle back and forththrough the bypass channels 139 i, 139 o over the course of repeatedintake and expel strokes. Eventually, sufficient air may gather in thechamber 103 a to cause the pump 100′ to operate less efficiently or tostall. For example, as an increasing volume of air passes through thebybass channel 139 o to gather in a chamber 103 a, the amount of bloodthat can be drawn into the chamber 103 a and subsequently expelled fromthe chamber 103 a can decrease due to the presence of the air.

With reference again to FIG. 9C, in certain embodiments, the pump 100comprises a mounting hook 175. In some embodiments, the mounting hook175 extends from the valve plate 170 in a direction substantiallyorthogonal to a plane defined by a base surface of the valve plate 170.The mounting hook 175 can define an opening 175 a. In some embodiments,the hook 175 extends in substantially the same direction as the bosses176 a-d. The hook 175 and bosses 176 a-d are further discussed below.

In some embodiments, the double diaphragm pump 100 is constructed withthe inlet and outlet valve chambers 101 i, 101 o, 102 i, 102 o and thepump chambers 103 a, b located on the same side of the pump body 110.The pump chambers 103 a, b can also be located on opposite sides of thepump body 110 while the inlet and outlet valves 101 i, 102 i, 101 o, 102o can be located on the opposite side of the pump body 110 from theirassociated pump chamber 103 a, b. The pump body 110 can be constructedwith more than two pump cavities 103 a, b, more than two inlet valves101 i, 102 i, and more than two outlet valves 112 i, 112 o tocooperatively work in pumping a single fluid. Also, multiple doublediaphragm pumps 100 can be constructed on a single pump body 110. Thediaphragms 140 a, b, 150 a, b can also have more valve regions 151 i,151 o, 152 i, 152 o and pump chamber regions 141 a, 141 b than thoseshown in the depicted embodiments.

Components of the double diaphragm pump 100, or portions thereof, thatare exposed to a process fluid (such as, for example, blood) can beconstructed of any suitable material that is compatible with the processfluid. For example, in some embodiments, the pump 100 comprises anysuitable blood-compatible material, whether currently known in the artor yet to be devised. Examples of such candidate materials can includeplastic materials, such as polycarbonate (PC), polyvinyl chloride (PVC),polypropylene (PP), polyethylene (PE), polytetrafluoroethylene (PTFE),polyperfluoroalkoxyethylene (PFA), fluorinated ethylene propylene (FEP),and polyurethane (PU). In some embodiments, metal materials can be used,such as stainless steel 316L and/or titanium. In some embodiments, thebody 110 is constructed of PC. The body 110 can be substantially rigidand relatively inflexible, in some arrangements.

In certain embodiments, the chamber diaphragms 140 a, 140 b and valvediaphragms 150 a, 150 b may be formed from a polymer or an elastomer. Insome embodiments, polymers that have high endurance to cyclic flexingmay be used, such as, for example, a fluorpolymer, such aspolytetrafluoroethylene (PTFE), polyperfluoroalkoxyethylene (PFA), orfluorinated ethylene propylene (FEP). Other non-elastomer film materialsmay be used, such as PE, PVC, PP. In some embodiments, an elastomericmaterial such as silicone or polyurethane can be used for the diaphragms140 a, b, 150 a, b. In certain of such embodiments, it is preferablethat supporting structures be configured so as to prevent plastic hinges(e.g., relatively sharp bends in material where the diaphragm is forcedby pressure into contact with features in the actuation cavities) thatmay cause cyclic failure.

In some embodiments, components of the pump 100 that do not contact aprocess fluid can be constructed of any of a variety of materialswithout consideration of possible incompatibilities among the materialsand the process fluid. For example, in some embodiments, materials usedfor the chamber plate 160 and valve plate 170 can be any suitableplastic or metal material. In many embodiments, the chamber plate 160and the valve plate 170 are substantially rigid and can be relativelyinflexible.

The inlet line 180 i and outlet line 180 o can be made from any suitablematerial, and can be compatible with the process fluid. In someembodiments, the lines 180 i, 180 o comprise a blood compatible PVCmaterial containing softening plasticizers, such as Tygon® S-95-E tubingavailable from Saint Gobain Performance Plastics, Akron, Ohio.

FIG. 11 illustrates an embodiment of a pump 1100. The pump 1100 caninclude features such as those described above with respect to theillustrated embodiments of the pumps 100 and 100′. Accordingly, featuresof the pump 1100 are identified with reference numerals incremented by1000 relative to reference numerals used to identify like features ofthe pumps 100, 100′.

In certain embodiments, the pump 1100 can be in fluid communication withan inlet line 1180 i and an outlet line 1180 o. The pump 1100 cancomprise a pump body 1110, which can define an inlet channel 1138 i influid communication with the inlet line 1180 i and an outlet channel1138 o in fluid communication with the outlet line 1180 o. The pump 1100can further comprise a chamber plate 1160, which can cooperate with thepump body 1110 to at least partially define a first pump chamber 1103 a,a first inlet valve 1101 i, and a first outlet valve 1101 o. In someembodiments, one or more diaphragms 1140 are included between the pumpbody 1110 and the chamber plate 1160. The one or more diaphragms 1140can include one or more diaphragm actuations regions 1141 a, 1151 i,1151 o configured to move within the first pump chamber 1103 a, thefirst inlet valve 1101 i, and the first outlet valve 1101 o,respectively.

In some embodiments, the pump body 1110, the chamber plate 1160, and theone or more diaphragms 1140 further define a second pump chamber, asecond inlet valve, and a second outlet valve (not shown) such as theillustrated first pump chamber 1103 a, first inlet valve 1101 i, andfirst outlet valve 1101 o, respectively. The inlet channel 1138 i canextend between the first inlet valve 1101 i and the second inlet valve,and the outlet channel 1138 o can extend between the first outlet valve1101 o and the second outlet valve.

In some embodiments, the first inlet valve 1101 i includes a seat rim1135 i and the second inlet valve 1101 o includes a seat rim 1135 o. Thepump body 1110 can define a chamber channel 1133 i that provides fluidcommunication between the seat rim 1135 i of the first inlet valve 1101i and the first pump chamber 1103 a and can define another chamberchannel 1133 o that provides fluid communication between the pumpchamber 1103 a and the seat rim 1135 o of the first outlet valve 1101 o.In some embodiments, the diaphragm actuation region 1151 i is configuredto selectively permit fluid communication between the inlet channel 1138i and the chamber channel 1133 i. Similarly, the diaphragm actuationregion 1151 o can be configured to selectively permit fluidcommunication between the chamber channel 1133 o and the outlet channel1138 o.

In some embodiments, the chamber plate 1160 defines a motive fluidpassage 1173 i in fluid communication with the first inlet valve 1101 i,a motive fluid passage 1173 o in fluid communication with the firstoutlet valve 1101 o, and a motive fluid passage 1163 a a in fluidcommunication with the first pump chamber 1103 a. The motive fluidpassages 1173 i, 1173 o, and 1163 a can be at least partially defined bymotive fluid transfer bosses 1176 a, 1176 b, and 1162 a, respectively.In some embodiments, the bosses 1176 a, 1176 b, and 1162 a areconfigured to be connected with a motive fluid control device. In someembodiments, motive fluid is provided to the valves 1101 i, 1101 o andthe pump chamber 1103 a to actuate the diaphragm actuation regions 1151i, 1151 o, and 1141 a, respectively. In some embodiments, such as thatillustrated in FIG. 11, motive fluid at a first pressure can be providedto both the first inlet valve 1101 i and the first pump chamber 1103 a,and motive fluid at a second pressure can be provided to the firstoutlet valve 1101 o.

With reference to FIGS. 12-13B, in certain embodiments, a pump assembly450 can include a reusable control base or pump control system 451 andone or more double diaphragm pumps 100, 100 a. The control system 451and one or more diaphragm pumps 100, 100 a can be configured toselectively couple and decouple. In some embodiments, the one or morediaphragm pumps 100, 100 a can be used with the control system 451 in asingle procedure or a limited number of procedures, removed from thecontrol system 451, and then discarded. Additional diaphragm pumps 100,100 a can replace the discarded diaphragm pumps 100, 100 a in one ormore additional procedures. Accordingly, in some embodiments, thecontrol system 451 can be used in multiple procedures (whether of thesame or different variety) with a plurality of disposable diaphragmpumps 100, 100 a.

As further discussed below, in some embodiments, the control system 451can control the manner in which the pumps 100, 100 a operate. Thecontrol system 451 can operate a set of pumps 100, 100 a in a variety ofdifferent modes, depending on the type of procedure involved. In someembodiments, the control system 451 is reconfigurable, such that themanner in which the control system 451 controls the pumps 100, 100 a canbe altered. The control system 451 can comprise a fluid logic systemconfigured to direct motive fluids from different sources (e.g., motivefluids at different pressure levels) to different portions of each pump100, 100 a, and in further embodiments, can alternate which motivefluids sources are directed to the portions of the pumps 100, 100 a.

In certain embodiments, the control system 451 comprises a processor452, which can comprise any suitable logic processor or controller, andmay comprise, for example, an on-board computer. In some embodiments,the processor 452 is configured to run executable computer code, and caninclude volatile and/or non-volatile memory. In further embodiments, theprocessor 452 can be configured to communicate with other devices, andmay be part of a network.

In some embodiments, the control system 451 includes a user controlinterface 453. The interface 453 can be of any suitable variety, and canbe configured to communicate information to and/or from the processor452. For example, the interface 453 can include one or more displayscreens, touch screens, keyboards, mouse controllers, switches,indicators, and/or speakers. In some embodiments, instructions can beprovided to the processor 452 via the interface 453. For example, insome embodiments, the processor 452 is capable of operating in a varietyof different modes and the interface 453 can be used to select among theavailable modes. The interface 453 may also be used to program theprocessor 452 to operate in a new or different mode.

As further discussed below, in some embodiments, the control system 451comprises one or more pneumatic regulators and/or vacuum generators,which can control the pressure level of a pressure source 220 and/or avacuum source 230 (see FIG. 16); one or more motive fluid valves 210(see FIG. 16), which can comprise one or more air valves, and/or otherpneumatic control and conditioning devices; and/or other suitablecontrol hardware. In some embodiments, the pressure source and vacuumsource can be supplied to the control system by connections to externalsystems that are configured to supply pressurized gases or suction ofgases. In some embodiments, such components and devices can be incommunication with and/or controlled by the processor 452 (e.g. thesetting of the pneumatic regulators that control the pressure level in amotive fluid source may be controlled by the processor).

With continued reference to FIG. 12, in certain embodiments, the controlsystem 451 comprises an enclosure 454 and a manifold mounting assembly400. In some embodiments, the enclosure 454 and the manifold mountingassembly 400 cooperate to form a cavity in which one or more componentsof the control system 451 (e.g., the processor 452, pressure source 220,and/or vacuum source 230) are contained. The manifold mounting assembly400 can be configured to interface with one or more pumps 100, 100 a andto selectively couple the pumps 100, 100 a with the system 451. FIG. 12shows an embodiment of a pump 100 in locked engagement with the manifoldmounting assembly 400 and a second pump 100 a disengaged from themanifold mounting assembly 400. The illustrated embodiment isparticularly suited for use with one or two pumps 100, 100 a. In someembodiments, the mounting assembly 400 can be used with more pumps thanpumps 100, 100 a.

FIG. 14 illustrates a partially exploded perspective view of anembodiment of the manifold mounting assembly 400. The illustratedembodiment includes two pump mounting areas 405 a, b, each of whichincludes similar components and features. Accordingly, for convenienceand not by way of limitation, the following discussion may refer to afeature of one of the pump mounting areas 405 a, b without referring toa like feature of the other mounting area, or may refer to like featuresinterchangeably. Other embodiments can include more than two pumpmounting areas 405 a, b and/or can include pump mounting areas thatinclude dissimilar features.

In certain embodiments, each pump mounting area 405 a, b of the manifoldmounting assembly 400 comprises a manifold cover 402 a, b. The manifoldcover 402 b can extend over and substantially shield a series of airtransfer bosses 407 (see also FIG. 15). The cover 402 b can define anopening associated with each air transfer boss 407 of the manifoldmounting assembly 400 for receiving an air transfer boss 162 a,b or 176a-d of a pump 100 a. As further discussed below, the air transfer bosses162 a, b, 176 a-d of the pump 100 a can extend through the openings andinto the air transfer bosses 407. The manifold cover 402 b can furtherdefine an opening through which a mounting hook 175 can extend (seeFIGS. 9C and 13B).

In certain embodiments, each air transfer boss 407 can receive a sealingelement, such as an o-ring 431 a-e, to facilitate or enable creation ofa fluid-tight seal between the air transfer bosses 407 and the airbosses 162 a, b, 176 a-d of the pump 100 a. Once the o-rings 431 a-e arein place, the manifold cover 402 b can be placed over the air transferbosses 407 and secured to the manifold mounting assembly 400 via anysuitable fastener, such as one or more screws 434 a-d. In someembodiments, each o-ring 431 a-e is retained between and is influid-tight contact with a ridge of an air transfer boss 407 and anunderside of the manifold cover 402 b.

In some embodiments, the manifold mounting assembly 400 compriseslatches 403 a, b that interact with the mounting hook 175 (see FIGS. 9Cand 13B) of a pump 100 to selectively secure the pump 100 to themanifold mounting assembly 400. As depicted by double-headed arrows inFIGS. 12 and 13B, the latch 403 a can move outward or inward relative toa pump 100. In some embodiments, the latch 403 is moved inward relativeto the pump 100 and advanced through the mounting hook 175 to secure thepump 100 to the manifold mounting assembly 400, and is moved outwardrelative to the pump 100 and removed from the opening 175 a defined bythe hook 175 to permit removal of the pump 100 (see FIG. 13B).

In some embodiments, the latch 403 a comprises a catch 406 (see FIG.13B). The catch can provide leveraged force against the mounting hook175 as it is slid forward to assist in energizing the radial o-ringseals 431 a-f for creating sealed fluid interfaces between pump 100 andmanifold mounting assembly 400.

In certain embodiments, a screw 432 b and a washer 433 b are used inconjunction with a manifold plate 410 to constrain the motion andpositioning of latch 403 b. For example, in the embodiment illustratedin FIG. 13B, the screw 432 a extends through the washer 433 a, throughan opening in the latch 403 b, and into the manifold plate 410. In otherembodiments, one or more other mechanisms may be used to selectivelyattach a pump 100 to the manifold mounting assembly 400. For example,clips, bolts, screws, clamps, or other fasteners could be used.

With reference to FIGS. 13B and 14, in some embodiments, the manifoldmounting assembly 400 includes one or more brackets 435 a, b andfasteners 436 a-d, which can be used to secure the manifold mountingassembly 400 to enclosure 454.

With reference to FIG. 15, in certain embodiments, the manifold mountingassembly 400 includes air passages 417, 418 (see also FIGS. 13A and13B). In some embodiments, air passage 417 provides fluid communicationbetween a first supply port A and air transfer bosses 411, 415, and 416and air passage 418 provides fluid communication between a second supplyport B and air transfer bosses 412, 413, and 414. As further discussedbelow, in some embodiments, the supply ports A, B are in fluidcommunication with a motive fluid control valve 210 (see FIG. 16), whichcan be configured to selectively permit one or more motive fluids toflow to or from the supply ports A, B.

In some embodiments, when the pump 100 is connected to the controlsystem 451, the air transfer bosses 162 a, b, 176 a-d of the pump 100are in fluid communication with the air transfer bosses 411-416 of themanifold mounting assembly 400. For example, in some embodiments, theair transfer bosses 412, 413, and 414 are connected with air transferbosses 176 c, 162 b, and 176 b of the double diaphragm pump 100 toprovide for actuation of the second inlet valve 102 i, second pumpchamber 103 b, and first outlet valve 101 o. Similarly, the air transferbosses 411, 415, and 416, are connected with air transfer bosses 176 d,162 a, 176 a of the air diaphragm pump 100 to provide for actuation ofthe first inlet valve 101 i, first pump chamber 103 a, and second outletvalve 102 o.

In some embodiments, the air passages 417, 418 include restrictions 421,422, respectively. For example, the air passages 417, 418 can includetransfer passages to redirect the flow of motive fluid toward the airtransfer bosses 411-416 (see FIGS. 13A and 15). In some embodiments thetransfer passages associated with air transfer bosses 412 and 415 aresmaller than those associated with air transfer bosses 411, 413, 414,and 416. Accordingly, in some embodiments, the restrictions 421, 422comprise the smaller transfer passages, and can reduce the rate ofchange in motive fluid pressure in pump chambers 103 a, b by restrictingair flow through air transfer bosses 412 and 415 as compared with therate of change in motive fluid pressure in valve chambers by notsignificantly restricting air flow to or from the bosses 411, 413, 414,and 416. This permits the inlet and outlet valves to open and closerapidly relative to the filling and discharging of the pump chambers.Further, in some embodiments, the volume of the valves 101 i, 101 o, 102i, 102 o is also smaller than the volume of the pump chambers 103 a, b,which can permit the valves to remain open or closed during asubstantial portion of a given stroke cycle. In some embodiments,pressure sensors can be placed in fluid communication with the airtransfer passages on the pump side of the restrictions 421, 422. Theprocess fluid inlet pressure to the pump and outlet pressure from thepump can be monitored due to the motive fluid pressure at theselocations and the process fluid pressure are closely related when thediaphragm regions 141 a, b are not in an end-of-stroke position duringthe pump cycle.

In some embodiments, such as the embodiment illustrated in FIGS. 12-15,the control system 451 is capable of actuating the flow control valves101 i, 101 o, 102 i, 102 o and the pump chambers 103 a, b using a singlelevel of pressure in one of the passages 417, 418 and a single level ofsuction in the other passage 417, 418 during a given stroke or portionof a stroke. Such a configuration can reduce the number of air valves,air regulators, and air control devices (such as those described below)used by the pump control system 451, which can, in some cases, reducethe manufacturing costs, reduce the complexity, decrease the potentialprobability of mechanical failure, and/or increase the ease of useand/or the reliability of the pump assembly 450.

FIG. 16 depicts a schematic illustration of another embodiment of thepump assembly 450, and includes like reference numerals to identify likefeatures disclosed in other figures of the present disclosure. The pumpassembly 450 can comprise a motive fluid logic system 460 configured tocontrol a double diaphragm pump 100. In some embodiments, the motivefluid logic system 460 comprises the control system 451 (see FIG. 12).The logic system 460 can comprise a processor 452 such as describedabove. In some embodiments, the processor 452 is in communication (e.g.,electrical, wireless, or other communication) with a valve controller212 and can control the operation thereof. As discussed above, in someembodiments, the processor 452 is pre-programmed with one or moreoperational modes by which it controls the controller 212, and infurther embodiments, the processor 452 can be reconfigurable.

In some embodiments, the valve controller 212 is configured to effecttransition of a motive fluid valve 210 among a variety of operationalstates. In some embodiments, the valve controller 212 comprises anelectrical actuator (or controller) or a pneumatic actuator (orcontroller), which can transition the valve 210 among the operationalstates.

In some embodiments, the valve 210 is configured to operate in two ormore positions and may include a resting state, a first state, and asecond state. In the illustrated embodiment, the resting, disconnected,closed, or shutoff state of the valve 210 corresponds with the middlerectangular section, the first operational state corresponds with thetop rectangular section, and the second operational state correspondswith the bottom rectangular section. In some embodiments, the restingstate of the valve 210 substantially prevents fluid communicationbetween the pump 100 and the pressure source 220 and vacuum source 230.The valve 210 can be positioned in this state, for example, duringinstallation and removal of the pump 100 or during a pump “off”condition or pump “shut down” condition.

In some embodiments, the valve 210 provides fluid communication betweena pressure source 220 and the supply port A and between a vacuum source230 and the supply port B when in the first state, and provides fluidcommunication between the pressure source 220 and the supply port B andbetween the vacuum source 230 and the supply port A when in the secondstate. As indicated by the double-headed arrow, in some embodiments, thevalve 210 passes through the resting state when transitioning betweenthe first and the second operational states. Other arrangements of thevalve 210 are also possible. For example, the first and secondoperational states of the valve 210 can be positioned adjacent to eachother such that the valve 210 does not pass through the resting state intransitioning between the first and second operational states. In otherembodiments, multiple motive fluid valves 210 can be used.

The pressure source 220 can comprise any suitable source of motive fluidsuch as, for example, an air compressor, a pressurized canister,connection to a pressurized air line, etc. Similarly, the vacuum source230 can comprise any suitable source of motive fluid (or, in someinstances, a relative lack thereof), such as, for example, a connectionto a rarefied air line or a vacuum generator or an air compressorconfigured to evacuate or partially evacuate a chamber. In someembodiments, the vacuum source 230 comprises a vent to atmosphere, andthe pressure source 220 is pressurized to a level that exceeds that ofatmospheric pressure. In some embodiments, the pressure source 220and/or the vacuum source 230 can comprise one or more pneumaticregulators to help achieve a relatively constant pressure level. As anexample, in some embodiments, the pressure source 220 can comprise afirst motive fluid, such as compressed air at a first pressure level(e.g., about 300 mmHg (millimeters of mercury)), and the vacuum source230 can comprise a second motive fluid, such as rarefied air at a secondpressure level (e.g., about −200 mmHg vacuum pressure).

In certain embodiments, the pump 100 is in fluid communication with aprocess fluid source 238, which can comprise any fluid for which pumpingis desired. For example, in some medical applications, the process fluidsource 238 comprises blood circulating in the vasculature of a patient.Other fluids at a variety of pressures and/or at a variety of viscositylevels are also possible. The pump 100 can be in fluid communicationwith the process fluid source 238 via the inlet line 180 i. The pump 100can further be in fluid communication with a process fluid destination,discharge, receiver, or return 239 via the outlet line 180 o. In someembodiments, the process fluid source 238 and the process fluid return239 are at about the same pressure. In other embodiments, the processfluid source 238 is at a lower pressure than the process fluid return239. Other arrangements and configurations are also possible.

FIG. 16 illustrates that the motive fluid of pressure source 220 and thevacuum source 230, respectively, are in selective fluid communicationwith pump 100 via the manifold mounting assembly 400. In certainembodiments, the vacuum source 220 (which may be a vent) can be at apressure that is less than the process fluid source 238 pressure toallow intake of the process fluid into the pumping chambers, and thepressure source 230 can be at a pressure level that is greater than thatof the process fluid return 239. The pressure levels or suction levelscan be selectively controlled by pressure regulators (not shown in FIG.16) or other devices to the desired levels for pumping the processfluid. In various embodiments, the pressure level of motive fluidprovided by the pressure source 220 can be between about 0 mmHg andabout 1000 mmHg, between about 50 mmHg and about 500 mmHg, or betweenabout 100 mmHg and about 200 mmHg. In various embodiments, the pressurelevel of motive fluid provided by the vacuum source 230 can be betweenabout −500 mmHg and about 0 mmHg, between about −250 mmHg, or betweenabout −100 mmHg and about −50 mmHg.

In some embodiments, the control valve 210 is alternated betweenoperational states to cyclically apply pressure and vacuum to supplyports A and B prior to the chamber diaphragms 140 a, b reaching theend-of-stroke or pump chamber surfaces 114 a, 114 b and/or the chambercavity surfaces 165 a, b. In certain of such embodiments, the pressureand flow of the process liquid at the process fluid receiver 230 can bemaintained at a substantially constant level.

In certain embodiments, as the pump 100 causes fluid to flow from theprocess fluid source 238 to the process fluid return 239, the flow canbe restricted by the capacities of fluid carrying components that may belocated between the process fluid source 238 and the inlet line 180 iand/or between the outlet line 180 o and the process fluid receiver 239.In some embodiments, the pressure levels of the pressure source 220and/or the vacuum source 230 and/or the operational speed or cyclingrate of the valve 210 can be adjusted to achieve a desired flow rate ofthe process fluid.

In certain embodiments, the pressure levels of the sources 220, 230and/or the cycling rate (or rates) of the valve 210 can be selectivelychanged to cause the double diaphragm pump 100 to operate in one or moredifferent desired operating modes. For example, in a first illustrativemode, the valve 210 can switch the first supply port A from being influid communication with the pressure source 220 to being in fluidcommunication with the vacuum source 230 and can substantiallysimultaneously switch the second supply port B from being in fluidcommunication with the vacuum source 230 to being in fluid communicationwith the pressure source 220. The change in supply sources 220, 230 cancause the chamber diaphragms 140 a, b to switch stroke direction priorto one of the pump chambers 103 a, b being completely filled and priorto the other pump chamber 103 a, b being completely emptied. With thepump chambers 103 a, b operating opposite from each other (e.g., onechamber 103 a draws process fluid from the fluid source 238 while theother chamber 103 b expels process fluid to the fluid return 239), thepump 100 can draw process fluid and expel process fluid at asubstantially constant rate.

In another mode, the pump 100 can be controlled to provide asubstantially constant draw pattern or fill rate and a pulsatiledischarge pattern by adjusting the cyclic speed of the control valve210, the vacuum level of the vacuum source 230, and/or the pressurelevel of the pressure source 220. For example, in some embodiments, oneof the chamber diaphragm regions 141 a, b can switch stroke directionprior to completely filling one of the chambers 103 a, b with processfluid when the valve 210 transitions from an open state to a closedstate, and can completely discharge the contents of the chamber 103 a, band contact one of the chamber cavity surfaces 114 a, b for a period oftime before the valve 210 transitions from the closed state back to theopen state. Likewise, the other chamber diaphragm region 141 a, b canreach the end-of-stroke condition when it completely discharges thecontents of the other chamber 103 a, b and can be in contact with theother chamber cavity surface 114 a, b for a period of time prior to thevalve 210 transitioning from a closed state to an open state, and canfail to reach the fill end-of-stroke condition of the chamber 103 a, bwith process fluid prior to the valve 210 transitioning from the openstate back to the closed state.

Similarly, in yet another mode, the pump can operate in a pulsatile fillpattern and substantially constant discharge pattern. In certain of suchembodiments, one of the chamber diaphragm regions 141 a, b can permitone of the chambers 103 a, b to completely fill with process fluid andcan contact one of the cavity surfaces 165 a, b for a period of timebefore the valve 210 transitions from a substantially full state to apartially emptied state, and can fail to completely discharge thecontents of the chamber 103 a, b before the valve 210 transitions fromthe partially emptied state back to the substantially full state.Likewise, the other chamber diaphragm region 141 a, b can fail tocompletely discharge the contents of the other chamber 103 a, b beforethe valve 210 transitions from a partially emptied state to asubstantially full state, and can permit the other chamber 103 a, b tocompletely fill with process fluid and can contact the other cavitysurface 165 a, b for a period of time before the valve 210 transitionsfrom the substantially full state back to the partially emptied state.

Other embodiments of supplying motive fluid to the double diaphragm pump100 are also possible. For example, in some embodiments, multiple aircontrol valves 210 may be employed. In further embodiments, a commonmotive fluid supply to one or more of the valves 101 i, 101 o, 102 i,102 o and/or a common motive fluid supply provided to the pump chambers103 a, 103 b can instead be replaced with a separate supply of motivefluid to each valve 101, 102 and chamber 103. For example, certainembodiments of the two air transfer passages 417, 418 could be replacedwith six separate passages (one for each air transfer boss 411-416).

In some embodiments, the valves 101 i, 101 o, 102 i, 102 o and chambers103 a, b can be sequenced electronically to provide operating modes suchas those described above. In further embodiments, operating a pump in aflow forward mode and then in a flow reverse mode by changing thesequencing of actuating the valves 101 i, 101 o, 102 i, 102 o andchambers 103 a, b can also be achieved. In some embodiments, individualcontrol of the pump valves 101 i, 101 o, 102 i, 102 o and pump chambers103 a, b can also allow other pump operating modes that can createconstant (or substantially constant) and pulsatile flow from the processfluid source 238 to the process fluid receiver 239 (or vice versa). Insome embodiments, time delays between allowing fluid communicationbetween motive fluid sources (e.g., sources 220, 230) and one or more ofthe chambers 103 a, b and valves 101 i, 101 o, 102 i, 102 o usingindividual controls can be advantageous. For example, in someembodiments, it can be desirable to actuate one or more of the valves101 i, 101 o, 102 i, 102 o prior to actuating the chambers 103 a, b

FIG. 17 is a schematic illustration of an embodiment of acardiopulmonary by-pass system 700 that includes multiple doublediaphragm blood pumps 100 b-f. The system 700 can further include one ormore reservoirs 706, blood oxygenators 701, fluid conduits, such astubing segments 702, 705, catheters 704, 712, cannulae 703, 709, medicalfluid sources 711, heat exchangers, and/or filtration units. Certainembodiments of the system 700 include components and sub-systems thatare not shown in FIG. 17 for purposes of clarity. However, it will beunderstood that such components and sub-systems are conventional andreadily available from numerous well-known sources. In some embodiments,the system 700 uses cannulae that are either inserted directly into theright atrium of the heart (as illustrated in FIG. 17), to the vena cava,or at another desired location of the patient P. Interconnectionsbetween devices or components of the system 700 can include, in someembodiments, segments of surgical tubing. For example, in someembodiments, conventional ⅜ or ¼ inch inner diameter surgicalpolyvinylchloride tubing is used.

In certain embodiments, one or more of the diaphragm blood pumps 100 b-fmay have separately selectable and controllable pressure levels. Forexample, in some embodiments, each blood pump 100 b-f is connected to aseparate pressure source 220 and/or a separate vacuum source 230. Infurther embodiments, one or more of the pumps 100 b-f can include avalve 210 that cycles at a different rate. In some embodiments, one ormore of the pumps 100 b-f share a common pressure source 220 and/orvacuum source 230. In certain of such embodiments, pneumatic regulatorscan be placed in line from the main pressure source 220 and vacuumsource 230 to create unique pressure and/or suction levels for each pump100 b-f.

In some embodiments, one or more of the diaphragm blood pumps 100 b-fmay have separate motive fluid control valves 210, and one or morecontrollers 212 associated with each control valve 210 may operate thepumps 100 b-f at different rates, which may be dependant upon thefunction the pump serves within the cardiopulmonary by-pass system 700.In some embodiments, a single processor 452 controls the one or morevalve controllers 212 and the cycle rates or cycle patterns of the oneor more valves 210. In other embodiments, multiple processors mayprovide the pumps 100 b-f with different pumping rates and/or modes.

In certain embodiments, the reservoir 706 is supplied with blood flowfrom the patient P from the venous return catheter 704 via the venoustubing segment 705 and from the interconnections with the diaphragmblood pumps 100 c 100 d, and may be interconnected with other componentsof the system 700. Blood can be pumped from the reservoir 706 using adouble diaphragm blood pump 100 b, through the blood oxygenator 701, andback to the patient P via arterial tubing segment 702 and arterialcannula 703.

In some embodiments, the double diaphragm pump 100 b may be operated ina manner that provides pulsatile blood flow to the patient P through thearterial cannula 703. A time delay between the cyclically controlleddischarge of the pump chambers 103 a, b, such as described above, cancause the pump 100 b to create a more physiological “heart-like” flowthrough the circuit. Many of the components in the system 700 can act todampen the effect of pulsation created by the pump 100 b before theblood is returned to the patient P. In some embodiments, the pump 100 bcan be controlled to offset these effects. For example, in someembodiments, a processor 452 includes programmed instructions and/orimplements one or more algorithms to counteract pulsation dampeningprovided by the system 700. In some embodiments, the processor 452 canutilize information regarding the amount of dampening provided by thesystem to dynamically alter operation of the pump 100 b and therebyprovide a desired pulsatile pumping pattern. For example, in someembodiments, the system 700 includes one or more flow meters or pressuresensors (not shown) that provide information to the processor 452regarding the pressure and/or the flow rate of blood within the tubingsegment 702.

In certain embodiments, the pump 100 b operates in a mode that creates asubstantially constant flow into the venous return catheter 704 from thepatient P and a pulsatile outlet flow out of the arterial cannula 703and to the patient P. Dampening of the pump-created pulsations in thevarious reservoirs, tubing segments, and other devices in the circuitmay occur. The dampening effects can be offset by controlling the vacuumsource 220, pressure source 230, and pump cycle rate to cause the pump100 b to expel fluid at a faster rate than blood is drawn, which cancreate an end-of-stroke discharge condition during each pump stroke. Inother embodiments, the pump 100 b can exhibit substantially equivalentdischarge and fill times, which can create a substantially constant flowinto the venous return catheter 704 from the patient and a substantiallyconstant flow out of the arterial cannula 703 and into the patient P.Pump-created process fluid pressure pulsations can be dampened by thevarious reservoirs, tubing segments, and other devices in the circuitcausing a substantially uniform flow into and out of the extracorporealcircuit.

In certain embodiments, when the diaphragm blood pump 100 b is used toeffect blood flow both away from patient P, such as via the venousreturn catheter 704 and into the patient, such as via arterial cannula703, flow rates through the pump can be in a range of, for example,between about 1.0 and about 7.0 liters per minute, between about 1.0 andabout 5.0 liters per minute, between about 1.0 and about 3.0 liters perminute, no more than about 7.0 liters per minute, no more than about 6.0liters per minute, no more than about 5.0 liters per minute, no morethan about 4.0 liters per minute, no more than about 3.0 liters perminute, no less than about 1.0 liters per minute, no less than about 2.0liters per minute, or no less than about 3.0 liters per minute,depending on the medical procedure involved.

With continued reference to FIG. 17, blood may be removed and recoveredfrom a surgical field via one or more suction devices 713 that can bepositioned or manipulated in the surgical field and interconnected to adiaphragm blood pump 100 c. Examples of such a suction device that canbe suitable for operation with the pump 100 c are available, forexample, from Medtronic DLP, Inc. of Grand Rapids, Mich.

Blood can also be recovered through the vent catheter 712, which may beplaced inside a cavity of the heart or other cavity of a patient towithdraw blood and control the pressure or suction level inside thecavity. In such applications, it can be desirable to operate the pump100 d with near uniform suction by cyclically switching the filling anddischarge of the pump chambers 103 a, b before the diaphragms reach anend-of-stroke fill position. The recovered blood may be sequestered in aseparate reservoir (not shown) and may be selectively returned to thereservoir 706. The recovered blood may also be processed through asystem (not shown) configured to clean the blood before it is returnedto the reservoir 706. In some embodiments, flow rates through thediaphragm blood pumps 100 c, 100 d used to effect blood flow frompatient P via the suction device 713 and the vent catheter 712 to thereservoir 706 can be in the range of between about 0 and about 1.0liters/minute, depending on the medical procedure being performed.

As shown in FIG. 17, in some embodiments, a medical fluid source 711 iscoupled with a pump 100 f. In some embodiments, the medical fluid source711 comprises cardioplegia fluid, which can be mixed with blood andsupplied to the patient P by operation of the diaphragm blood pumps 100e, f. In some embodiments, controlling the cardioplegia fluid mixtureand delivery rate (e.g., before returning the mixture to the patient P)can be accomplished by controlling the discharge pressure of one or moreof the pumps 100 e, f. For example, in some embodiments the pressurelevel of one or more pressure sources 220 and/or vacuum sources 230associated with one or more of the pumps 100 e, f can be adjusted. Insome embodiments, the process fluid discharged from one or more of thepumps 100 e, f can be passed through one or more flow restrictors (notshown). In certain embodiments, the rate of flow can be nearly constantat a given pressure difference across the restrictors, even with smallchanges in fluid conditions, such as temperature and/or viscosityfluctuations.

In some embodiments, one or more flowmeters (not shown) can be includedin the outlet fluid lines of one or more of the pumps 100 e, f and cansense the flow rate of fluid discharged from the pumps 100 e, f. The oneor more flowmeters can provide feedback information regarding the flowrate to one or more processors 452 that control the pumps 100 e, f. Insome embodiments, the pressure level in the pressure source 220 and/orthe vacuum source 230 can be adjusted in response to the feedbackinformation to cause the flow rate from the pumps 100 e, f to increaseor decrease to obtain a desired level of mixing and a desired deliveryrate of mixed fluid to the patient P. In some embodiments, the cyclerate at which diaphragm actuation regions of a given pump 100 e, f areactuated can be adjusted to provide increased or decreased fluid flowfrom that pump 100 e, f. In certain embodiments, appropriately mixedand/or heated or cooled cardioplegia fluid can be delivered via a tubingsegment and cardioplegia cannula 709 to the patient P.

In certain embodiments, the pumps 100 b-f can provide desirable pressurelevels for the system 700. In some embodiments, the pumps 100 b-f may besafer than pumps conventionally used in some of the applicationsdescribed above, such as roller pumps. For example, if a vascular accessconnection to the patient P is somehow degraded or a blockage occurs inthe system 700 (e.g., via a kink in a portion of tubing), certainembodiments of the pumps 100 b-f have limited capability to generatehigh pressure and/or high suction levels that may damage the blood inthe system 700 and/or that might otherwise be hazardous to the patientP. For example, in some embodiments, the pressure sources 220, 230 canbe at pressure levels that limit the amount of pressure and/or suctionprovided to extracorporeal blood within the system 700. In variousembodiments, the pressure of extracorporeal blood within the system iswithin a of between about −250 mmHg and about 500 mmHg, between about−200 mmHg and about 400 mmHg, or between about −100 mmHg and about 300mmHg. In some embodiments the pressure of extracorporeal blood withinthe system 700 is no less than about −250 mmHg, no less than about −200mmHg, no less than about −150 mmHg, no less than about −100 mmHg, nogreater than about 500 mmHg, no greater than about 400 mmHg, no greaterthan about 300 mmHg, or no greater than about 200 mmHg.

Further, some embodiments of the pumps 100 b-f do not significantlyraise the temperature of blood within the system 700 if a vascularaccess connection to the patient P is somehow degraded or a blockageoccurs in the system 700. In various embodiments, the pumps 100 b-fchange (e.g., raise) the temperature of extracorporeal blood within thesystem 700 by no more than about 3° C., no more than about 4° C., nomore than about 5° C., or no more than about 6° C.

FIG. 18 is a schematic illustration showing an embodiment of aheart-assist system 750 that comprises a double diaphragm pump 100 g.The pump 100 g can be attached to an inlet line 180 i and an outlet line180 o. In the illustrated embodiment, the inlet line 180 i providesfluid communication between the vasculature of the patient P and thepump 100 g. In some embodiments, the inlet line 180 i is attached to alower pressure blood vessel, such as a vein or ventricle, via a cannulaor an anastomosis attachment 753. Similarly, the outlet line 180 o canbe attached to a higher pressure blood vessel, such as an artery oraorta, via a cannula or anastomosis attachment 754. In some embodiments,each of the inlet lines 180 i and outlet lines 180 o comprises a tubingsegment. The tubing sections may be percutaneous and can allow the pump100 g to run externally to the patient P.

In some embodiments, the heart-assist system 750 comprises additionalcomponents and devices that are known in the art (not shown). Forexample, in various embodiments, the heart-assist system 750 comprisesone or more reservoirs, air bubble traps, filters, and/or other devices.

In various embodiments, the system 750 can provide flow rates to or fromthe patient P in the range of about 1.0 liters/minute to about 8.0liters/minute, depending on the amount of heart support needed. Incertain embodiments, the pump 100 g comprises pump chambers 103 a, 103 bthat each have a volume of between about 15 cubic centimeters and about50 cubic centimeters, between about 20 cubic centimeters and about 30cubic centimeters, no more than about 25 cubic centimeters, or about 25cubic centimeters. In some embodiments, the pump 100 g is operated at arate between about 10 and about 200 cycles per minute, between about 90and about 130 cycles per minute, between about 100 and about 120 cyclesper minute, no more than about 200 cycles per minute, no more than about150 cycles per minute, no more than about 120 cycles per minute, no lessthan about 10 cycles per minute, no less than about 50 cycles perminute, no less than about 100 cycles per minute, or about 120 cyclesper minute. In various embodiments, the pump 100 g can deliver blood tothe patient P at a rate between about 2 liters per minute and about 8liters per minute, between about 3 liters per minute and about 7 litersper minute, or between about 4 liters per minute and about 6 liters perminute. In certain embodiments, the volume of the pump chambers 103 a,103 b of a pump 100 g and the number of cycles per minute at which thepump 100 g operates can be adjusted to provide a desired flow rate. Infurther embodiments, relatively lower cycles per minute can lengthen thelife expectancy of the pump 100 g and/or can aid in providing pulsatileblood flow to a patient that mimics a heartbeat.

FIG. 19 schematically illustrates a hemodialysis system that includes anextracorporeal circuit 800. In certain embodiments, the circuit 800includes a diaphragm pump 100 h, a dialyzer 810, and a dialyzing liquidsystem 820. The circuit 800 can be in fluid communication with a patientP. Blood can be withdrawn from the patient P at a blood source 238 andcan be returned to the patient P at a blood receiver 239. Blood can flowthrough the circuit 800 in the direction of the arrows. In theillustrated embodiment, blood flows from the patient P to a drip chamber803 via tubing 802, from the drip chamber 803 to the pump 100 h viatubing 805, and from the pump 100 h to the dialyzer 810 via tubing 807.Blood flows from the dialyzer 810 to a drip chamber 812 via tubing 811,and from the drip chamber 811 to the patient P via tubing 814.

In some embodiments, uptake from the process fluid source 238 anddischarge to the process fluid receiver 239 occurs via needles puncturedinto an artery to vein fistula or graft shunt, or alternatively, from acatheter positioned in a large central vein. In certain embodiments, forthe portion of the circuit 800 between the patient P and the pump 100 h,blood pressure can be measured and monitored by means of a pressuresensor, such as a piezo-resistive pressure transducer 804 a that can beconnected to the drip chamber 803, whereby a hydrophobic membrane filter(not shown) serves to prevent contamination of the blood. Similarly,venous reflux pressure in the portion of the circuit 800 betweendialyzer 810 and the patient P can be measured by means of a pressuretransducer 804 b. Pressure sensors can be used at other portions of thecircuit 800. For example, in some embodiments, pressure sensors can beused to monitor the pressure levels of blood entering and exiting thepump 100 h. Pressure sensors can also be used to determine the pressurelevels of motive fluid provided to the pump 100 h.

In certain embodiments, the blood pump 100 h effects the flow of bloodin the extracorporeal circuit 800. In some embodiments, a heparin pump808 provides for continuous feed of a desired heparin dose to preventblood coagulation. The dialyzing liquid system 820 causes dialyzingliquid to flow through the dialyzer 810 and acts as a receiver of excessfluid and toxins removed from the blood that flows through the dialyzer.In some embodiments, the components of the extracorporeal blood circuit800 are connected with each other via suitable safety devices known inthe art or yet to be devised.

In some embodiments, an air detector 825 is included between thedialyzer 810 and the patient P. The air detector 825 can be configuredto prevent infusion of blood foam or air, which may have entered theextracorporeal circuit 800, into the patient P. In some embodiments, theair detector 825 recognizes whether air bubbles or microfoam are presentin the drip chamber 812 or elsewhere in the circuit 800. The airdetector 825 can be in communication with a processor 452 (see, e.g.,FIG. 16), which may switch off the blood pump 100 f in response toinformation received from the detector 825.

In other embodiments, the pump 100 h may similarly be deactivated inresponse to other information regarding the circuit 800. For example,the sensors 804 a, b may detect an undesirable increase or decrease ofthe arterial or venous pressure above or below a threshold level. Theinformation can be used to deactivate the pump 100 h. Similarly, thepump 100 h may be deactivated as a result of a blood leak. In someembodiments, the pump 100 h may be operatively associated with a controlsystem 451, which may include an interface 453. In some embodiments, theinterface 453 can display or otherwise signal information received fromsensors within the circuit 800.

In some embodiments, information regarding the pressure of blood in thecircuit 800, such as information provided by one or more of the pressuretransducers 804 a, b, is used to adjust the pressure level of motivefluid delivered to the pump 100 h. For example, in some embodiments, thepressure transducers 804 a, b, are configured to communicate with aprocessor 452 (see, e.g., FIG. 12), such as by one or more electrical orwireless connections. The processor 452 can utilize the information thusreceived to selectively control the pressure levels of motive fluiddelivered from motive fluid sources, such as the sources 220, 230, in amanner such as described above (e.g., via one or more pressureregulators) and/or to control cycle rates and stroke durations of thepump 100 h. For example, in some embodiments, the pressure levels of themotive fluid from the pressure sources 220, 230 and the cycle rates atwhich fluid communication is alternately established between distinctsets of valves and pump chambers is adjusted such that substantiallyconstant fluid flow is established from the patient P to theextracorporeal circuit 800 and/or from the extracorporeal circuit 800 tothe patient P. In some embodiments, the pump 100 h provides pulsatileflow to the dialyzer 810 and essentially constant flow from the patientP to the extracorporeal circuit 800.

In certain embodiments, the pump 100 h can provide desirable pressurelevels for the extracorporeal circuit 800. In some embodiments, the pump100 h may be safer than conventional dialysis pumps, such as rollerpumps. For example, if the vascular access connection to the patient issomehow degraded or a blockage occurs in the extracorporeal circuit 800(e.g., via a kink in a portion of tubing), certain embodiments of thepump 100 h have limited capability to generate high pressure and/or highsuction levels that may damage the blood in the circuit 800 and/or thatmight otherwise be hazardous to the patient P. Further, some embodimentsof the pump 100 h does not significantly raise the temperature of bloodwithin the circuit under such conditions of connection degradation orblockage.

In some embodiments, the diaphragm blood pump 100 f generates twooverlapping substantially square wave inflow pressure profiles andoutflow pressure profiles during the pumping cycle which can result in asubstantially constant blood inflow pressure and/or a substantiallyconstant blood outflow pressure. The inflow and outflow pressures can beset near or within safety limits to provide maximum process fluid flowwithout triggering pressure limit alarms. The pressure profile generatedby conventional roller pumps used in hemodialysis procedures is somewhatsinusoidal and may only operate at the maximum pressure level for ashort duration of the pumping cycle. Accordingly, in some embodiments,as compared with such conventional pumps, the pump 100 h can achievehigher blood flows at the same peak pressure limits. Higher flow ratescan reduce the duration of a given hemodialysis procedure. In someembodiments, the inflow rate and/or the outflow rate of the pump 100 hcan be controlled or balanced (e.g., via the processor 452) to besubstantially continuous with little pulsation of pressures or flow, ascompared to some roller pumps that cannot simultaneously control theinflow pressure, outflow pressure, and flowrate. In other embodiments,the pump 100 h can be configured to operate in a manner similar toconventional roller pumps, if desired.

Non-limiting examples will now be discussed with reference to FIGS. 20,21, 22A, and 22B. These examples provide illustrations of performancecapabilities of some embodiments, and are not intended to limit theforegoing disclosure in any respect.

Example 1

FIG. 20 is a chart showing an example of pressure over time during asingle pump cycle of an embodiment of a pump 100 b used in a simulationof a cardiopulmonary bypass system such as the system 700 of FIG. 17.The chart depicts the pressure over time of blood entering the pump 100b (illustrated by the curve “Pump In”) and also depicts the pressureover time of blood exiting the pump 100 b (illustrated by the curve“Pump Out”). In the illustrated example, the pump 100 b was operated ina mode for approximately uniform flow entering an extracorporeal circuitand approximately uniform flow exiting the circuit.

Various operational parameters of the pump 100 b of the present exampleor of other embodiments of the pump 100 b can be altered such that theinflow pressure for the extracorporeal circuit and the outflow pressurefor the extracorporeal circuit are more uniform than that shown. Forexample, in some embodiments, the valley of the “Pump Out” line at thetime coordinate of 0.2 seconds is relatively more shallow (e.g., has aminimum value of between about 200 and about 300 mmHg) and/or may berelatively more constricted (i.e., span over a shorter time period).Similarly, in some embodiments, the peak of the “Pump In” line at thetime coordinate of 0.2 seconds is smaller (e.g., has a maximum valve ofbetween about 0 and about 100 mmHg) and/or may be relatively moreconstricted.

In some embodiments, the inflow to the pump 100 b and outflow from thepump 100 b are approximately uniform. As used herein, the term“approximately uniform” when used to describe a flow rate is a broadterm and signifies that over a single pump cycle, the maximum flow ratedeviates from the average flow rate by no more than about 25% of theaverage flow rate during the pump cycle.

As discussed above, in some embodiments, flow and pressure pulsationscreated by a pump 100 b can be dampened by the various reservoirs,tubing segments, and other devices in a circuit, and can result in moreuniform flow rates and pressures. In certain embodiments, the uptakeflow rate at a blood source 238 (e.g., a patient) and/or a delivery flowrate at a blood delivery destination 239 (e.g., a patient) can beessentially constant during a pump cycle. As used herein, the term“essentially constant” when used to describe a flow rate is a broad termand signifies that over a single pump cycle, the maximum flow ratedeviates from an average flow rate by no more than about 10% of theaverage flow rate during the pump cycle. The pump 100 b used to createthe chart of FIG. 20 comprised two chambers, each having a displacementvolume of about 25 milliliters. The chart illustrates the pump 100 b ashaving operated at 200 millisecond per stroke (i.e., 400 millisecond percycle or 150 cycles per minute). The pressure level in the pressuresource 220 was established at 390 mmHg, the level of suction in thesuction source was established at −125 mmHg, and the flow rate of bloodeffected by pump 100 b was about 4 to 5 liters per minute. Connectionslines 180 i and 180 o were comprised of plasticized PVC tubing with aninner diameter of 0.375 inches.

Example 2

FIG. 21 is a chart showing an example of pressure over time during asingle pump cycle of an embodiment of a pump 100 g used in a simulationof a heart assist system such as the system 750 of FIG. 18. The chartdepicts the pressure over time during a single pump cycle of bloodentering the pump 100 g (illustrated by the curve “Pump In”) and alsodepicts the pressure over time of blood exiting the pump 100 g(illustrated by the curve “Pump Out”). The pump 100 g was operated in amode for relatively uniform flow entering an extracorporeal circuit andpulsatile outflow from the circuit.

Various operational parameters of the pump 100 g of the present exampleor of other embodiments of the pump can be altered such that the inflowto the extracorporeal circuit is more uniform than that shown. Forexample, in some embodiments, the peak of the “Pump In” line at the timecoordinate of about 0.45 seconds is smaller (e.g., has a maximum valveof between about 20 and about 80 mmHg) and/or may be relatively moreconstricted. Similarly, the pulsatile characteristics of the outflowfrom the extracorporeal circuit may be modified, as briefly discussedbelow.

The pump 100 g used to create the chart of FIG. 21 comprised twochambers with each chamber having a displacement volume of about 25milliliters. The chart illustrates the pump 100 g as having operated at500 millisecond per stroke (i.e., 1 second per cycle or 60 cycles perminute). The pressure level in the pressure source 220 was establishedat 300 mmHg and the level of suction in the suction source wasestablished at 0 mmHg. The flowrate of blood effected by pump 100 g wasaround 3 liters per minute. Shorter more pronounced pulse widths can begenerated by extending the cycle time or increasing the pressure levelin the pressure source 220. The pump was located about 30 inches belowthe fluid source 238 creating a positive pressure head of about 50 mmHg.Connections lines 180 i and 180 o were comprised of plasticized PVCtubing with an inner diameter of 0.375 inches. The outlet line 180 oinner diameter was further reduced to 0.25 inches inner diameter forsimulating a percutaneous access and arterial connection 754. The bloodflowing through the connection lines caused pressure drops to and fromthe pump and the blood was delivered to the blood return 239 at lessthan 100 mmHg. The blood pump 100 g of the illustrated example cancreate high pressures in the blood to overcome line losses, and as aresult, a much smaller lumen can be used to access the vasculature of apatient P.

Example 3A

FIG. 22A is a chart showing an example of pressure over time during asingle pump cycle of an embodiment of a pump 100 h used in a simulationof a hemodialysis system such as the system 800 of FIG. 19. The chartdepicts the pressure over time during a single pump cycle of bloodentering the pump 100 h (illustrated by the curve “Pump In”), thepressure over time of blood exiting the pump 100 h (illustrated by thecurve “Pump Out”), and also depicts the pressure over time of bloodexiting the dialyzer 810 (illustrated by the curve “Dialyzer Out”). Thepump 100 h was operated in a mode for relatively uniform flow enteringthe circuit and relatively uniform flow exiting the extracorporealcircuit.

The chart illustrates the pump 100 h as having operated at 3 seconds perstroke (i.e., 6 seconds per cycle or 10 cycles per minute). The pressurelevel in the pressure source 220 was established below about 390 mmHg,which caused the dialyzer out pressure to remain below about 250 mmHg,and the level of suction in the suction source was established aboveabout 250 mmHg. The pump 100 h used to create the chart of FIG. 22Acomprised two chambers with each chamber having a displacement volume ofabout 25 milliliters. The flowrate of blood effected by pump 100 h wasabout 250 to about 350 milliliters per minute. Connection lines 180 iand 180 o were comprised of plasticized PVC tubing with an innerdiameter of 0.25 inches and connected to a commonly used disposablehemodialysis circuit with 16 gauge hemodialysis needles as theconnections to fluid source 238 and fluid return 239. Most of theflow-driven pressure losses in the hemodialysis circuit 800 occurredthrough the needles and the dialyzer 810.

Example 3B

FIG. 22B is a chart showing an example of pressure over time during asingle pump cycle of an embodiment of a pump 100 h used in a simulationof a hemodialysis system such as the system 800 of FIG. 19. The chartdepicts the pressure over time during a single pump cycle of bloodentering the pump 100 h (illustrated by the curve “Pump In”), thepressure over time of blood exiting the pump 100 h (illustrated by thecurve “Pump Out”), and also depicts the pressure over time of bloodexiting the dialyzer 810 (illustrated by the curve “Dialyzer Out”). Thepump 100 h was operated in a mode for relatively uniform flow enteringthe circuit and pulsatile flow exiting the extracorporeal circuit.

The pump 100 h is illustrated as having operated at 3 seconds per stroke(i.e., 6 seconds per cycle or 10 cycles per minute). Shorter, morepronounced pulse widths can be generated by extending the cycle time orincreasing the pressure level in the pressure source 220. The pressurelevel in the pressure source 220 was established below about 360 mmHg,which caused the dialyzer out pressure to remain below about 250 mmHg,and the level of suction in the suction source was established aboveabout −160 mmHg. The pump 100 h used to create the chart of FIG. 22Bcomprised two chambers with each chamber having a displacement volume ofabout 25 milliliters. The flowrate of blood effected by pump 100 g wasabout 200 to about 300 milliliters per minute. Connections lines 180 iand 180 o were comprised of plasticized PVC tubing with an innerdiameter of 0.25 inches and connected to a commonly used disposablehemodialysis circuit with 16 gauge hemodialysis needles as theconnections to fluid source 238 and fluid return 239. Most of thehemodialysis circuit blood flow pressure losses occurred through theneedles and the dialyzer 810. A more pronounced pulsation can beachieved at a given flowrate with a combination of longer cycle times,larger bore needles, and lower flow resistance of the dialyzer.

Various features and structures discussed herein, and equivalentsthereof, can provide specific functionalities. By way of illustration,in some embodiments, the first and second pump chambers 103 a, b areexamples of first and second means for selectively drawing process fluidfrom a process fluid source (e.g., the fluid source 238) and selectivelyexpelling process fluid to a process fluid delivery destination (e.g.,the process fluid delivery destination 239); the first and second inletvalves 101 i, 102 i are examples of first and second means forselectively permitting process fluid to flow to the first and secondmeans for selectively drawing process fluid from a process fluid sourceand selectively expelling process fluid to a process fluid deliverydestination, respectively; and the first and second outlet valves 101 o,102 o are examples of first and second means for selectively permittingprocess fluid to flow from the first and second means for selectivelydrawing process fluid from a process fluid source and selectivelyexpelling process fluid to a process fluid delivery destination,respectively.

As used in this specification, including the claims, the term “and/or”is a conjunction that is either inclusive or exclusive. Accordingly, theterm “and/or” either signifies the presence of two or more things in agroup or signifies that one selection may be made from a group ofalternatives.

Without further elaboration, it is believed that one skilled in the artcan use the preceding description to utilize the claimed inventions totheir fullest extent. The examples and embodiments disclosed herein areto be construed as merely illustrative and not a limitation of the scopeof the present disclosure in any way. It will be apparent to thosehaving skill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples discussed. In other words, various modifications andimprovements of the embodiments specifically disclosed in thedescription above are within the scope of the appended claims. Forexample, any suitable combination of features of the various embodimentsdescribed is contemplated. Note that elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. §112 ¶6. The scope of the invention is therefore definedby the following claims.

1-29. (canceled)
 30. A medical fluid pumping apparatus comprising: a first member defining first, second, and third cavities; a second member defining a first cavity, the second member being disposed adjacent the first member such that the first cavity of the second member is aligned with the first cavity of the first member; a first preshaped diaphragm region disposed between the first and second members, the first preshaped diaphragm region cooperating with the first cavity of the first member to at least partially define a motive fluid portion of a pumping chamber, the first preshaped diaphragm region cooperating with the first cavity of the second member to at least partially define a medical fluid portion of the pumping chamber, the first preshaped diaphragm separating the motive fluid portion of the pumping chamber from the medical fluid portion of the pumping chamber; a second preshaped diaphragm region disposed between the first and second members, the second preshaped diaphragm region cooperating with the second cavity of the first member to at least partially define a motive fluid portion of an inlet valve, the second preshaped diaphragm region cooperating with the second member to at least partially define a medical fluid passage of the inlet valve, the second preshaped diaphragm region separating the motive fluid portion of the inlet valve from the medical fluid passage of the inlet valve, the second preshaped diaphragm region being configured to have a substantially convex shape when unstressed and a non-convex shape when pressure is applied to the second preshaped diaphragm region by motive fluid in the motive fluid portion of the inlet valve such that the medical fluid passage of the inlet valve is openable and closable by actuation of the second preshaped diaphragm region using motive fluid in the motive fluid portion of the inlet valve; and a third preshaped diaphragm region disposed between the first and second members, the third preshaped diaphragm region cooperating with the third cavity of the first member to at least partially define a motive fluid portion of an outlet valve, the third preshaped diaphragm region cooperating with the second member to at least partially define a medical fluid passage of the outlet valve, the third preshaped diaphragm region separating the motive fluid portion of the outlet valve from the medical fluid passage of the outlet valve, the medical fluid passage of the outlet valve being openable and closable by actuation of the third preshaped diaphragm region using motive fluid in the motive fluid portion of the outlet valve, the third preshaped diaphragm region being configured to have a substantially convex shape when unstressed and a non-convex shape when pressure is applied to the third preshaped diaphragm region by motive fluid in the motive fluid portion of the inlet valve such that the medical fluid passage of the outlet valve is openable and closable by actuation of the third preshaped diaphragm region using motive fluid in the motive fluid portion of the inlet valve, wherein the first preshaped diaphragm region is configured to draw medical fluid from a medical fluid source into the medical fluid portion of the pumping chamber and to pump medical fluid out of the medical fluid portion of the pumping chamber when the medical fluid pumping apparatus is connected to the medical fluid source and to one or more motive fluid sources and the first preshaped diaphragm region is actuated by motive fluid, and the second and third preshaped diaphragm regions are configured to respectively control medical fluid flow into and out of the medical fluid portion of the pumping chamber when the medical fluid pumping apparatus is connected to the medical fluid source and to the one or more motive fluid sources and the second and third preshaped diaphragm regions are actuated by motive fluid.
 31. The medical fluid pumping apparatus of claim 30, wherein and the medical fluid is blood.
 32. The medical fluid pumping apparatus of claim 31, wherein the medical fluid source is a patient.
 33. The medical fluid pumping apparatus of claim 32, wherein the medical fluid pumping apparatus is configured to draw blood from the patient into the medical fluid pumping apparatus and to pump blood from the medical fluid pumping apparatus to the patient.
 34. The medical fluid pumping apparatus of claim 30, wherein the first, second, and third diaphragm regions are separate diaphragms.
 35. The medical fluid pumping apparatus of claim 30, wherein a single diaphragm forms the first, second, and third diaphragm regions.
 36. The medical fluid pumping apparatus of claim 30, wherein the second preshaped diaphragm region is configured to have the non-convex shape when positive pressure is applied to the second preshaped diaphragm region by motive fluid in the motive fluid portion of the inlet valve.
 37. The medical fluid pumping apparatus of claim 36, wherein the third preshaped diaphragm region is configured to have the non-convex shape when positive pressure is applied to the third preshaped diaphragm region by motive fluid in the motive fluid portion of the outlet valve.
 38. The medical fluid pumping apparatus of claim 30, wherein the second and third preshaped diaphragm regions are configured to transition from the convex shape to the non-convex shape without substantially stretching.
 39. The medical fluid pumping apparatus of claim 30, wherein the first preshaped diaphragm region is configured to have a substantially convex shape when unstressed and a non-convex shape when pressure is applied to the first preshaped diaphragm region by motive fluid in the motive fluid portion of the pumping chamber.
 40. The medical fluid pumping apparatus of claim 39, wherein the first preshaped diaphragm region is configured to have the non-convex shape when positive pressure is applied to the first preshaped diaphragm region by motive fluid in the motive fluid portion of the pumping chamber.
 41. The medical fluid pumping apparatus of claim 39, wherein the first preshaped diaphragm region is configured to transition from the convex shape to the non-convex shape without substantially stretching.
 42. The medical fluid pumping apparatus of claim 39, wherein the first preshaped diaphragm region is configured to have a dome shape when unstressed and an oppositely directed dome shape when pressure is applied to the first preshaped diaphragm region by motive fluid in the motive fluid portion of the pumping chamber.
 43. The medical fluid pumping apparatus of claim 30, further comprising a third member adjacent the second member, the first member and the third member being on opposite sides of the second member.
 44. The medical fluid pumping apparatus of claim 30, further comprising an inlet line in fluid communication with the inlet valve to permit medical fluid to flow into the inlet valve, and an outlet line in fluid communication with the outlet valve to receive medical fluid that flows out of the outlet valve.
 45. The medical fluid pumping apparatus of claim 30, wherein the first member defines a first motive fluid passage in fluid communication with the motive fluid portion of the pumping chamber, a second motive fluid passage in fluid communication with the motive fluid portion of the inlet valve, and a third motive fluid passage in fluid communication with the motive fluid portion of the outlet valve, wherein the first, second, and third motive fluid passages are configured to permit motive fluid to pass therethrough to effect movement of the first, second, and third preformed diaphragm regions, respectively.
 46. The medical fluid pumping apparatus of claim 45, wherein the first, second, and third motive fluid passages are configured to be placed in fluid communication with the one or more motive fluid sources.
 47. A medical fluid pumping apparatus comprising: a first member defining a pump chamber cavity, an inlet valve seat, and an outlet valve seat; a first preshaped diaphragm region cooperating with the pump chamber cavity of the first member to at least partially define a medical fluid portion of a pumping chamber, the first preshaped diaphragm separating a motive fluid portion of the pumping chamber from the medical fluid portion of the pumping chamber; a second preshaped diaphragm region cooperating with the inlet valve seat of the first member to at least partially define a medical fluid passage of an inlet valve, the second preshaped diaphragm region separating a motive fluid portion of the inlet valve from the medical fluid passage of the inlet valve, the second preshaped diaphragm region being configured to have a substantially convex shape when unstressed and a non-convex shape when pressure is applied to the second preshaped diaphragm region by motive fluid in the motive fluid portion of the inlet valve such that the medical fluid passage of the inlet valve is openable and closable by actuation of the second preshaped diaphragm region using motive fluid in the motive fluid portion of the inlet valve; and a third preshaped diaphragm region cooperating with the outlet valve seat of the first member to at least partially define a medical fluid passage of an outlet valve, the third preshaped diaphragm region being configured to have a substantially convex shape when unstressed and a non-convex shape when pressure is applied to the third preshaped diaphragm region by motive fluid in the motive fluid portion of the inlet valve such that the medical fluid passage of the outlet valve is openable and closable by actuation of the third preshaped diaphragm region using motive fluid in the motive fluid portion of the inlet valve, wherein the first preshaped diaphragm region is configured to draw medical fluid into the medical fluid portion of the pumping chamber via the medical fluid passage of the inlet valve and to pump medical fluid out of the medical fluid portion of the pumping chamber via the medical fluid passage of the outlet valve when the medical fluid pumping apparatus is connected to a medical fluid source and to one or more motive fluid sources and the first preshaped diaphragm region is actuated by motive fluid, and the second and third preshaped diaphragm regions are configured to respectively control medical fluid flow into and out of the medical fluid portion of the pumping chamber when the medical fluid pumping apparatus is connected to the medical fluid source and to the one or more motive fluid sources and the second and third preshaped diaphragm regions are actuated by motive fluid.
 48. The medical fluid pumping apparatus of claim 47, wherein and the medical fluid is blood.
 49. The medical fluid pumping apparatus of claim 48, wherein the medical fluid source is a patient.
 50. The medical fluid pumping apparatus of claim 49, wherein the medical fluid pumping apparatus is configured to draw blood from the patient into the medical fluid pumping apparatus and to pump blood from the medical fluid pumping apparatus to the patient.
 51. The medical fluid pumping apparatus of claim 47, wherein the first, second, and third diaphragm regions are separate diaphragms.
 52. The medical fluid pumping apparatus of claim 47, wherein a single diaphragm forms the first, second, and third diaphragm regions.
 53. The medical fluid pumping apparatus of claim 47, wherein the second preshaped diaphragm region is configured to have the non-convex shape when positive pressure is applied to the second preshaped diaphragm region by motive fluid in the motive fluid portion of the inlet valve.
 54. The medical fluid pumping apparatus of claim 53, wherein the third preshaped diaphragm region is configured to have the non-convex shape when positive pressure is applied to the third preshaped diaphragm region by motive fluid in the motive fluid portion of the outlet valve.
 55. The medical fluid pumping apparatus of claim 47, wherein the second and third preshaped diaphragm regions are configured to transition from the convex shape to the non-convex shape without substantially stretching.
 56. The medical fluid pumping apparatus of claim 47, wherein the first preshaped diaphragm region is configured to have a substantially convex shape when unstressed and a non-convex shape when pressure is applied to the first preshaped diaphragm region by motive fluid in the motive fluid portion of the pumping chamber.
 57. The medical fluid pumping apparatus of claim 56, wherein the first preshaped diaphragm region is configured to have the non-convex shape when positive pressure is applied to the first preshaped diaphragm region by motive fluid in the motive fluid portion of the pumping chamber.
 58. The medical fluid pumping apparatus of claim 56, wherein the first preshaped diaphragm region is configured to transition from the convex shape to the non-convex shape without substantially stretching.
 59. The medical fluid pumping apparatus of claim 56, wherein the first preshaped diaphragm region is configured to have a dome shape when unstressed and an oppositely directed dome shape when pressure is applied to the first preshaped diaphragm region by motive fluid in the motive fluid portion of the pumping chamber.
 60. The medical fluid pumping apparatus of claim 47, wherein further comprising a second member adjacent the first member.
 61. The medical fluid pumping apparatus of claim 60, wherein the first preshaped diaphragm region is disposed between the first and second members.
 62. The medical fluid pumping apparatus of claim 61, wherein the second member defines a cavity aligned with the pump chamber cavity of the first member, the cavity of the second member forming the motive fluid portion of the pumping chamber.
 63. The medical fluid pumping apparatus of claim 60, wherein the second and third preshaped diaphragm regions are disposed between the first and second members.
 64. The medical fluid pumping apparatus of claim 63, wherein the second member defines cavities aligned with the inlet and outlet valve seats of the first member, the cavities of the second member forming the motive fluid portions of the inlet and outlet valves.
 65. The medical fluid pumping apparatus of claim 60, wherein further comprising a third member adjacent the first member, the second member and the third member being on opposite sides of the first member.
 66. The medical fluid pumping apparatus of claim 47, further comprising an inlet line in fluid communication with the inlet valve to permit medical fluid to flow into the inlet valve, and an outlet line in fluid communication with the outlet valve to receive medical fluid that flows out of the outlet valve.
 67. The medical fluid pumping apparatus of claim 47, wherein the second member defines a first motive fluid passage in fluid communication with the motive fluid portion of the pumping chamber, a second motive fluid passage in fluid communication with the motive fluid portion of the inlet valve, and a third motive fluid passage in fluid communication with the motive fluid portion of the outlet valve, wherein the first, second, and third motive fluid passages are configured to permit motive fluid to pass therethrough to effect movement of the first, second, and third preformed diaphragm regions, respectively.
 68. The medical fluid pumping apparatus of claim 67, wherein the first, second, and third motive fluid passages are configured to be placed in fluid communication with the one or more motive fluid sources. 